MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER

Model Number EX1150

Device Problem Failure to Power Up (1476)

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

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

Final analysis found burn marks on the ac power adapter and circuit board which caused the reported inability to power the transmitter.It was concluded that the damage sustained occurred after exposure to a high current flow from the power outlet.

Event Description

It was reported that the merlin transmitter did not power up and was damaged after a lightning strike.The device was replaced.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7122078
• MDR Text Key: 95052648
• Report Number: 2017865-2017-36149
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/15/2017

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: EX1150
• Other Device ID Number: 05414734504799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR