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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) MERLIN@HOME, RF TELEMETRY BASIC PACEMAKER DATA TRANSMITTER Back to Search Results
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.
 
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Brand NameMERLIN@HOME, RF TELEMETRY BASIC
Type of DevicePACEMAKER 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 Key8606270
MDR Text Key144920047
Report Number2938836-2019-03678
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received05/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2019
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

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