MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD MERLIN PROGRAMMER; PACEMAKER PROGRAMMER

Model Number 3650

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2014

Event Type  malfunction  

Manufacturer Narrative

Final analysis found the power supply defective.

Event Description

It was reported that the programmer was working but smelled of burned components.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: MERLIN PROGRAMMER
• Type of Device: PACEMAKER PROGRAMMER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3665227
• MDR Text Key: 11782813
• Report Number: 2017865-2014-10673
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 03/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2014
• 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