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

Model Number 2090

Device Problems Mechanical Problem (1384); Device Emits Odor (1425); Overheating of Device (1437); Electrical Shorting (2926); Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after just a few minutes of being plugged in and running, the programmer shut down suddenly while still being switched on and plugged in.Attempting with a different power cord and electrical socket did not resolve the issue.It was noted that, after the third attempt, there was a smell of shorted-out material in the programmer, and one of the fans was warm while the other was not.The programmer is expected to be returned for repair.There was no patient involvement.

Manufacturer Narrative

Product event summary: manufacturer¿s analysis could not confirm the customer comment regarding the programmer shutting down.It was confirmed, however, that the power supply was emitting an unusual smell, and was warmer than normal.It was also found that the liquid crystal display (lcd) intermittently went blank, both keyboard hinges were broken, both upper display hinges were broken, and the keyboard was missing screws.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8405756
• MDR Text Key: 138298555
• Report Number: 2182208-2019-00483
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994175397
• UDI-Public: 00613994175397
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• 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: 03/11/2019
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2003
• 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