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 02/07/2017

Event Type  malfunction  

Event Description

It was reported that the patient was in a nursing facility, the nurse reported that the transmitter would start up and no leds luminated.The nurse was instructed by our technical support to unplug the ac adapter from power outlet and remove the metal connector prongs to expose the circuitry inside the ac power adapter, the nurse reported the circuits appeared charred.The unit would be 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6464444
• MDR Text Key: 71911637
• Report Number: 2017865-2017-02104
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

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
• Other Device ID Number: 05414734504799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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