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

Model Number 2090

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: at analysis it was determined that the printed circuit board (pcb) had a component failure - cause unknown, the spacer lem board was broken, and the stylus tip position on the touch screen required calibration.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer required planned maintenance and repairs.The program was returned for service.No patient complications have been reported as a result of this event.It was further reported that the programmer tested out of specification during manufacturer's analysis.

• Brand Name: CARELINK PROGRAMMER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10021782
• MDR Text Key: 189763865
• Report Number: 2182208-2020-00860
• Device Sequence Number: 1
• Product Code: KRG
• 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,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• 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: 03/24/2020
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1