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

Model Number 2090AA4

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the reported programmer crashing and displaying error messages.The hard drive was replaced.The device passed final functional and system tests.No other anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer crashed while attempting to interrogate an implantable pulse generator (ipg) and then displayed an error message.The programmer was rebooted and then showed an additional error message.The programmer was returned for service.There was no patient involvement.

Manufacturer Narrative

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: 7674421
• MDR Text Key: 113750307
• Report Number: 2182208-2018-01262
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902824692
• UDI-Public: 00721902824692
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090AA4
• Device Catalogue Number: 2090AA4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2003
• 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