MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 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 Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not available.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient experienced a lightning storm and the transmitter failed to power up.The ac adapter prongs were removed, and it was noted that they were burnt inside.The cause was suspected to be due to the lightning storm as the transmitter did not cause fire and there was no smoke and it was not caused due to an electrical short circuit.

Manufacturer Narrative

(updated method code, results code and conclusion code).The field complaints of the transmitter unable to power up and burnt and damaged prongs were confirmed.Visual inspection revealed no physical damage to the outer housing of the merlin@home transmitter or to the outer casing of the ac power adapter.However, the green contact strips in the ac power adapter were inspected and a strong burnt odor from inside was noted.Burn marks were found on both sides of the main printed circuit board (pcb) and on its inner casing of the ac power adapter.Upon further inspection, slightly burnt components were noted on the main printed circuit board (pcb) of the transmitter.It was concluded that the device was hit by a high current flow through the ac electrical power outlet during a lightning storm as reported from the field which damaged the ac power adapter and respective main printed circuit board (pcb) which lead to the transmitter failing to power up.

• Brand Name: MERLIN@HOME, RF TELEMETRY BASIC
• Type of Device: PACEMAKER DATA TRANSMITTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8606270
• MDR Text Key: 144920047
• Report Number: 2938836-2019-03678
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 05414734504799
• UDI-Public: 05414734504799
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 71 YR