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

Model Number EX1150

Device Problem Charred (1086)

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

Event Date 09/15/2014

Event Type  malfunction  

Event Description

It was reported that the transmitter would not power up.The patient removed the adapter from the wall, the metal posts appeared charred.The device would be replaced.

Manufacturer Narrative

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

• 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: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4237441
• MDR Text Key: 4975728
• Report Number: 2017865-2014-19204
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial

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: EX1150
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 80 YR