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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. MERLIN@HOME, RF TELEMETRY BASIC PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Information (3190)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
Failure event observed during analysis. Final analysis found that upon opening the ac power adapter, inspection revealed that there were burnt components on both sides of the main pcb. Inspection of the opened transmitter revealed that there was no damage to the main pcb or to its¿ inner housing. The original ac power adapter was replaced to test the transmitter with the ac power adapter. The unit was then plugged into a working ac electrical wall outlet and the power on function was performed successfully. The test revealed that the burnt damage to the original ac power adapter was the cause of the no power issue. As a result, we can conclude that the transmitter was hit by a high current flow through the ac wall power outlet into the ac power adapter, thus damaging its¿ main pcb.
 
Event Description
This report is to advise of an event observed during analysis.
 
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Brand NameMERLIN@HOME, RF TELEMETRY BASIC
Type of DevicePACEMAKER DATA TRANSMITTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8189468
MDR Text Key131156791
Report Number2017865-2018-18755
Device Sequence Number1
Product Code DRG
UDI-Device Identifier05414734504799
UDI-Public05414734504799
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEX1150
Device Catalogue NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2018
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

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