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

Model Number EX1150

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

The field complaint of the transmitter being damaged after lightning struck the home was verified.Visual inspection indicated physical damage to the outer casing of the ac power adapter as it was broken and burnt damage to green contact strips on the prongs was also noted.Further, inspection of transmitter noted that the u-14 chip was physically damaged.Final analysis found burn marks on the main printed circuit board (pcb) of the ac power adapter and multiple 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 during electrical storm as reported from the field which damaged the ac power adapter and respective main pcb.

Event Description

It was reported that the transmitter was damaged due to lightning that struck home phone system.Troubleshooting was performed and it was noted that there was no power and entire system blew up.The transmitter was replaced.

• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7883443
• MDR Text Key: 120520132
• Report Number: 2938836-2018-10649
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 05414734504799
• UDI-Public: 05414734504799
• 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,user facility
• Type of Report: Initial
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2018
• 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: 76 YR