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

Model Number EX1150

Device Problems Break (1069); Thermal Decomposition of Device (1071); Failure to Power Up (1476)

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

Event Date 10/10/2017

Event Type  malfunction  

Event Description

It was reported that merlin transmitter was not working.After a power outage, there were burns noted on the transmitter and the internal cables of the power cord were exposed.The device was replaced.

Manufacturer Narrative

Final analysis found that the field complaint of the internal cables of the power cord being exposed was verified.However, the complaint of the transmitter being burnt could not be verified.Visual inspection of the power cord revealed that the a.C.Power adapter was missing and there were exposed wires.Further inspection of the transmitter showed no burn marks or damage.The transmitter functioned normally and powered on successfully after replacing the a.C.Power adapter.

• 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: 6960288
• MDR Text Key: 90078949
• Report Number: 2017865-2017-33325
• 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,Followup
• Report Date: 06/19/2018

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
• Other Device ID Number: 05414734504799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 06/19/2018
• Supplement Dates FDA Received: 11/08/2017; 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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: 76 YR