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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 Problems Thermal Decomposition of Device (1071); Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2018
Event Type  malfunction  
Event Description
It was reported that after a power outage, the merlin transmitter would not power up. The patient attempted to use a different outlet with no success. Upon disconnecting the prongs, a burn was noted. The transmitter was replaced.
 
Manufacturer Narrative
Final analysis found burn marks on the main printed circuit board, power adapter, and green contacts which resulted in the power up anomaly. It was concluded that during the power outage the merlin transmitter was hit by a high current flow through the ac wall power outlet into the ac power adapter and through the telephone line into the transmitter, thus damaging their respective main pcb.
 
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Brand NameMERLIN@HOME, RF TELEMETRY BASIC
Type of DevicePACEMAKER 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 Key7692028
MDR Text Key114145264
Report Number2017865-2018-10403
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,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEX1150
Device Catalogue NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/24/2018
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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