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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); Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Date 01/02/2019
Event Type  malfunction  
Event Description
It was reported that the transmitter might have caught fire while plugged into a bad wall socket. The device emitted an electrical burning smell and it was noted the transmitter adapter was burned and the plastic on the adapter was melted. The wall socket was fixed; the transmitter would not power up. The transmitter was replaced.
 
Manufacturer Narrative
Final analysis found the transmitter presented with a power issue. It was verified that the prongs of the plug adapter on the ac power adapter were indeed burnt/melted; however, there was no other visible damage to the outer plastic housing of the transmitter or to the rest of the ac power adapter. After replacing the original prong, the unit powered on successfully.
 
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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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8248157
MDR Text Key133068552
Report Number2017865-2019-00659
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2019
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 Manufacturer01/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
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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