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

Model Number 3650

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Analysis description: final analysis found excess dust in the power supply, which led to a rise in temperature within the programmer.The damage found likely contributed to the reported burn of the device.

Event Description

It was reported that prior to an implant procedure, the programmer exhibited a burning smell and no longer turned on.The unit was no longer used and was replaced.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PACEMAKER PROGRAMMER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: ulla strindlund ; box 7051; isafjordsgatan 15; kista SE-16-407 ; SW SE-16407 ; 4684744043
• MDR Report Key: 5640573
• MDR Text Key: 44721105
• Report Number: 3010215456-2016-03051
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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