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

Model Number 3650

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

It was reported that during device interrogation, the physician noted an electrical burning odor followed by white smoke coming from the power plug port of the merlin programmer.The power was turned off and the power cable removed.The device would no longer be used.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.(b)(4).

• 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: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4752643
• MDR Text Key: 16608378
• Report Number: 2017865-2015-04526
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• 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: 05/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: No
• 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