MAUDE Adverse Event Report: ABBOTT MERLIN PROGRAMMER; PACEMAKER PROGRAMMER

Model Number 3650

Device Problems Failure to Power Up (1476); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event of failure to power up was confirmed by analysis.Final analysis found a failed inverter board to be the cause of the failure to power up.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found the power switch made a crackling sound and emitted sparks when turned on.Testing confirmed a failed power switch was the cause of the sparks.The power supply and inverter board were replaced to resolve the event.

Event Description

The programmer was returned to the manufacturer when it would not power up.This report is to advise of an event observed during analysis.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PACEMAKER PROGRAMMER
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 9331476
• MDR Text Key: 166707227
• Report Number: 2017865-2019-15613
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1