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

Model Number 2090W

Device Problems Connection Problem (2900); Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the reported damaged universal serial bus (usb) port and that the programmer would reboot when attempting to use the usb port.The micro processor unit (mpu) was replaced.Analysis also noted that the electrocardiogram (ecg) connector was loose, the keyboard hinges were broken, and the tabs of the power cord bay door were broken.All damaged and defective parts were replaced.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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer had a broken universal serial bus (usb) port and would reboot when attempting to attach a usb cable to the port.The programmer was returned for service.There was no patient involvement.

• 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: 7500485
• MDR Text Key: 107825908
• Report Number: 2182208-2018-00874
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994127631
• UDI-Public: 00613994127631
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

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: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2006
• 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