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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN@HOME, RF TELEMETRY BASIC; PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
Failure event observed during analysis.Final analysis found burn marks on the printed circuit board (pcb) and on its inner casing which resulted in the transmitter to be unable to function as intended.
 
Event Description
This report is to advise of an event observed during analysis.
 
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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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8902876
MDR Text Key154624562
Report Number2017865-2019-12482
Device Sequence Number1
Product Code DRG
UDI-Device Identifier05414734504799
UDI-Public05414734504799
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Was the Report Sent to FDA? No
Date Manufacturer Received08/14/2019
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 Number1
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