complaint handling and product return for us sales...

Complaint Handling and Product Return for US Sales Work Instructions

This document is electronically controlled. Printed copies are considered uncontrolled.

Medtronic Confidential CRM.0201.0003.1 Version 7.0 Page 1 of 10

Cardiac Rhythm Disease Management

1.0 Purpose This Work Instruction provides instruction CRDM US Sales and CRDM US Sales and Service Operations for filing a complaint and return product.

2.0 Scope This document provides work instructions to the CRDM Field Sales Personnel and any other field personnel required to file a complaint and return product when processing a complaint and return explanted product from the United States.

International Sales will be governed by their local geographical requirements.

3.0 References

Identifier Title None

4.0 Terms and Definitions Term Definition CRDM Field Reps Sales Representatives that have an assigned SAP territory number. CRDM Field Sales Personnel

U.S. CRDM Field Sales including Sales Reps, Clinical Specialists, Technical Field Engineers, District Sales Managers, District Managers.

Customer Complaint Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

Device Tracking The scope of device tracking for the US Sales begins from the time product is transitioned in SAP (MDTs inventory tracking system) from the Distribution Center to the time of Device Registration in DART (Device and Registrant Tracking).

Medtronic Representative A member of the Medtronic Sales Organization who provides assistance to physicians during procedures using Medtronic product.

Non-Sales Stakeholders Non-sales s conducting activities to ensure quality and compliance of Medtronic product. For example, CRDM Audit, Customer Focused Quality, Customer Service, and Patient Registration Services.

Shall Must comply with this item Technical Services Medtronic central service organization which provides support to physicians

with questions on connectivity, compatibility, sterilization and usability, among other topics.

5.0 Roles and Responsibilities

Approval date:2.0DOC000461

nulldate27-Jun-2011 at 17:08 CDTDocument Type: Work Instruction

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Role Responsibilities

CRDM Field Sales Personnel

Responsible for collecting information from explanted product, notifying Technical Services, packaging and shipping product, and supporting MDR inquires. CRDM Field Sales Personnel includes: District Managers, District Service Managers, Sales Representatives, Clinical Specialists, and Field Technical Engineers.

6.0 Process

6.1 Collect Information from Explanted Product

Process Step: Collect Information from Explanted Product Process Step Role(s): CRDM Field Sales Personnel Process Responsibilities/Tasks: Collect any available information from explanted device and save information to disk if applicable. Any explanted product should be mailed within 72 hours following the procedure, regardless if it is the subject of a complaint. If the explanted product is not available for return, it is still important to collect information and return information on a disk (if applicable). NOTE: Do not reprogram device parameters prior to returning, with the following exceptions:

- Disable all tachyarrythmia detections - Disable patient alerts so the device does not beep

6.2 Notify Technical Services

Process Step: Notify Technical Services

Medtronic Confidential

CRM.0201.0003.1 Version 7.0 Page 2 of 10



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Process Step Role(s): CRDM Field Sales Personnel Process Responsibilities/Tasks:

1. CRDM Field Sales Personnel calls Technical Services within 24 hours of receiving information from physician/patient to register complaint.

6.3 Package and Return Explanted Product

Process Step: Package and Return Explanted Product to Product Return Analysis Lab Process Step Role(s): CRDM Field Sales Personnel Process Responsibilities/Tasks:

- Complete the Product Information Report (Attachment #1)

- Insert Product Information Report and product in question to Return Mailer Kit*.

* Return Mailer Kits can be ordered online via Product Literature

- UC200400460 EN for individual kits or UC199603290 EN for a case of 10 kits or,

- Send an email to: RS Product Lit Orders

NOTE: Return Mailer Kits can be requested any time and maintained in trunk stock.

- Pack the Return Mailer Kit to ensure safe shipment and proper analysis of returned products. (Attachment #2) - Ship Kit to Returned Product Analysis Lab within 72 hours from product explanted procedure.

7.0 Quality Record ACTIONS:

None





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Product Information Report must be completed for every complaint or returned product. Report can be found at: https://wwwp.medtronic.com/MdtFieldPortal/attachment/NEW-PIR-ReturnsAndComplaintsForm-201005450ENp4.pdf?categoryId=110160&itemId=1285785280832&dataId=1285785355611&filename=NEW-PIR-ReturnsAndComplaintsForm-201005450ENp4.pdf

ATTACHMENT #1





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Header Provides quick, easy to follow, directions on the procedure for complaint handling and return.

Section A is REQUIRED. Alert date is when Medtronic Representative first hears about an issue. This can include direct communication with the doctor / patient or overhearing a conversation in the hallway.

One of these boxes needs to be checked off.





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Report Completed by: Name of person filling out the form. Be sure to include phone number for any follow up questions. Also include the Report Date as this is used in tracking the timing of the complaint.

Patient Information: Fill out the name and date of birth of the patient. Check whether the patient is pacing dependent.

Reason: Why is the product being returned? If anything is checked in the shaded sections, Part B must also be filled in.

Be sure to check the appropriate box. If Other, please specify if known.





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Specific Product Information: Provide serial number of item removed as well as replacement product.

Physician / Hospital This is the physician who performed the procedure, not the follow up physician. Hospital information is where the procedure took place.

Section B: If anything has been completed in the shaded sections of Part A, then Section B is required. The more information that is provided in this section, the better the analysis and the fewer phones calls you will receive. If in doubt, send it along.

If patient has died: Fill out the date of death and cause (if known) Fill in any additional information surrounding the death if known. The more known, the better the analysis.

Copies: Return with Product Return; Hospital; Medtronic Representative





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Sample Product Information Report





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ATTACHMENT #2





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Cardiac Rhythm Disease Management Business and Quality Management System

CONFIDENTIAL DOCUMENT/

RECORD

This document/record is electronically controlled; printed copies are considered uncontrolled.

System of Record: QADoc

Name Version

Title:

Scope Document Type Author

APPROVALS

Signed By Meaning of Signature Date/Time (UTC)

DOC000461 2.0


Single Site Work Instruction Jaglowski, Betsy

Jaglowski, Betsy Process Owner 27-Jun-2011 14:55:56

Peterson, Mari Additional Approver 27-Jun-2011 21:37:41

Pan, Jennifer Quality Specialist 27-Jun-2011 22:08:26



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External References

1. 21 CFR

Part 820

2. 21 CFR

Part 210 and

211

3. 21 CFR

Part Other

Subpart I- Nonconforming Product

Not Applicable

Part 821- Medical Device Tracking Requirements



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4. ISO 13485

5. ISO Other

Standards

Section 4- Quality Management System Documentation

Not Applicable



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6. Other

Regulations

and

Standards

7.

Corporate

Policies

Not Applicable

Not Applicable



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Internal References

Document Name Title Relation Name

DOC000459 Complaint Handling and Product Return Procedure BQMS Doc to Doc



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Multi-Site Process Template1.0 Purpose2.0 Scope3.0 References4.0 Terms and Definitions5.0 Roles and Responsibilities6.0 Process6.1 Collect Information from Explanted Product6.2 Notify Technical Services6.3 Package and Return Explanted Product- Complete the Product Information Report (Attachment #1)- Insert Product Information Report and product in question to Return Mailer Kit*.

7.0 Quality Record

complaint handling and product return for us sales...

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