MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD MERLIN AT HOME RF; PACEMAKER DATA TRANSMITTER

Model Number EX1150C

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2013

Event Type  malfunction  

Event Description

It was reported that the patient was woken up during the night to a burn smell coming from the transmitter, the unit was hot.

Manufacturer Narrative

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

Manufacturer Narrative

Final analysis found burnt circuitry.

• Brand Name: MERLIN AT HOME RF
• Type of Device: PACEMAKER DATA TRANSMITTER
• 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: 3664811
• MDR Text Key: 4342746
• Report Number: 2017865-2014-10388
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX1150C
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2013
• Initial Date FDA Received: 03/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• 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