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

Model Number 2090

Device Problems No Display/Image (1183); Mechanical Problem (1384); Overheating of Device (1437); Operating System Becomes Nonfunctional (2996); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that upon plugging in and turning on the programmer, the device suddenly stopped working and smoke was emitted from the side fan vent.The programmer was then unplugged.The device is expected to be returned for service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was able to confirm the customers comment regarding the programmer.It was found that the device would not power up and a burn odor was noted.The power supply was replaced.Salvaged part was used for power supply.All salvaged part used was inspected per applicable requirements.The hard drive was reconfigured, reloaded, and it's software updated.The programmer passed final functional and system tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the programmers screen went black.The device has been returned for servicing.

• 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: 10049598
• MDR Text Key: 191550708
• Report Number: 2182208-2020-00895
• 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,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• 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: 05/12/2020
• Date Manufacturer Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2012
• 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