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

Model Number EX1150

Device Problems Charred (1086); Power Conditioning Problem (1474)

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

Event Date 04/05/2018

Event Type  malfunction  

Event Description

It was reported that a power pole by the patient's home was hit by lightning, and the merlin at home transmitter was damaged resulting in blackened prongs and would not power on.The device was returned and exchanged.

Manufacturer Narrative

Final analysis found the allegation of blackened prongs was not verified.The root-cause of the no power issue was that the ac power adapter's main pcb sustained damage through the ac electrical power outlet.

• 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: 7439873
• MDR Text Key: 105826426
• Report Number: 2017865-2018-05841
• 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,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• 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: 04/12/2018
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2013
• 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: 79 YR