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

Model Number 3650

Device Problems Smoking (1585); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2018

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 started smoking and fizzing in clinic.The programmer was switched off.The programmer still works, but makes a buzzing sound.No patient was involved in this incident.

Manufacturer Narrative

The field complaint of a buzzing sound was verified, but there were no indications of burn damage.During analysis, the programmer was plugged in add powered on.Once booted, there was noise coming from the speakers.The programmer was disassembled and inspected for signs of burning or smoke, but none were found.An internal anomaly was found to be the cause of the complaint.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PACEMAKER PROGRAMMER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8061648
• MDR Text Key: 126911527
• Report Number: 2938836-2018-12132
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 05414734500661
• UDI-Public: 05414734500661
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2011
• 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