MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number 3650

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the programmer turned on, started smoking, and an electrical smell was streaming out from all the vents.The programmer was immediately turned off.It was attempted to try and turn on the programmer again however, it would not power on.No patient was involved.

Manufacturer Narrative

The field complaint that the programmer had smoked and won't start was verified.During analysis, the unit was plugged into a working outlet and power on function was performed, but the unit did not power on.Analysis also observed that c19 had been electrically stressed causing excessive internal pressure which resulted in the release of electrolyte vapor.No signs of additional burning or fire were found.The "smoke" experienced in the reported event was the vapor released by the electrolytic capacitor.C19 is no longer functional in its current state causing the power supply to not power on.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10469142
• MDR Text Key: 204852886
• Report Number: 2017865-2020-12485
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

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: Health Professional
• Device Model Number: 3650
• Device Catalogue Number: 3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1