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

Model Number 2090W

Device Problems Corroded (1131); No Display/Image (1183); Problem with Software Installation (3013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the programmer was unable to perform a software update and had a damaged screen.Possible contamination was found only on the power supply.It was noted that the power supply looked contaminated but was functional.The hinge plate screws were missing.The keyboard hinges were broken.The hard drive health was is less than 100%.The programmer system fan was noisy.There were broken tabs on the power cord bay door.The programmer hard drive was reconfigured and the programmer software was reloaded and updated.All found defective parts were replaced and all other identified issues were resolved.The programmer 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 programmer was unable to perform a software update and had a damaged screen.Troubleshooting steps were advised however the issue was not resolved.The programmer was returned to service and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• 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: 13786431
• MDR Text Key: 287320650
• Report Number: 2182208-2022-00805
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00885074301440
• UDI-Public: 00885074301440
• 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
• Type of Report: Initial
• Report Date: 03/16/2022

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: 02/04/2022
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2005
• 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
• Treatment: 2067 RADIOFREQUENCY HEAD