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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 Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
The reported event of failure to power up was confirmed.Final analysis found burnt damage to the alternating current power adapter consistent with high current flow through a power outlet.However, the power cord did not smell burnt.
 
Event Description
It was reported that the patient's merlin @ home transmitter could not power up.The patient reported that the power cord smelt burnt.
 
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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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7711327
MDR Text Key114801267
Report Number2017865-2018-10727
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 consumer
Type of Report Initial
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberEX1150
Device Catalogue NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2018
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 Number1
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