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

Model Number EX1150

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

Section e : (b)(6) center.

Event Description

It was reported that no power was observed on the transmitter and scorch marks were observed on the transmitter's power adapter prongs.The transmitter with power adapter was replaced.There were no reported patient consequences.

Manufacturer Narrative

The field complaint of the transmitter not powering on was not verified.During the analysis, the transmitter could not be initially turned on as the alternating current (ac) power adapter had been cut off.The visual inspection revealed no damage to the outer plastic housing of the transmitter; however, the ac power adapter had been cut off and was no longer attached to the unit.- the unit was plugged into a working ac electrical wall outlet using ac power adapter tl# (b)(6).The ac power adapter had been cut off and removed.After opening the transmitter, no damages were observed on the main printed circuit board (pcb).

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15106477
• MDR Text Key: 296621338
• Report Number: 2017865-2022-16115
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504799
• UDI-Public: 05414734504799
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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: 60 YR