MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER

Model Number 2090

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer powered off expectantly and will no longer power on.A new power cord was used but the issue persisted.The programmer was returned for service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was able to confirm the programmer would not power up.Analysis noted that the printed circuit board (pcb) was contaminated.The power supply was replaced and the pcb was replaced and calibrated.The hard drive was reconfigured, and the software was reloaded and updated.The device passed final functional and system tests.No other anomalies were found.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8051867
• MDR Text Key: 126650111
• Report Number: 2182208-2018-02039
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994434937
• UDI-Public: 00613994434937
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0406-2019
• Patient Sequence Number: 1