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

Model Number 2090

Device Problems Computer Software Problem (1112); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was unable to reproduce the black screen error however a system error was recorded twice in the recent log file - the hard drive was reconfigured.Inspected and tested all three usb ports and no anomalies were observed.Inspected nylon standoff between link electronic module (lem) and micro processor unit (mpu) and no anomalies were noticed - replaced as a preventative.Power cord was missing - power cord was added.Inspected circuit boards and mechanical parts.Programmer failed thermal sensor 7 - the power supply was replaced.The software was reloaded and updated and 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 displayed a black screen error and there was a request to check the universal serial bus (usb) port function.The programmer was returned for service.It was further reported that the programmer 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: 10533952
• MDR Text Key: 206933199
• Report Number: 2182208-2020-01865
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994581570
• UDI-Public: 00613994581570
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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: 07/30/2020
• Date Manufacturer Received: 08/28/2020
• 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
• Treatment: 2067 RADIOFREQUENCY HEAD.