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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 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 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
Failure event observed during analysis. Final analysis found that the unit could not be plugged in due to electric shock hazard. A visual inspection of the power cord revealed exposed wires. There was no damage to outer plastic housing of the transmitter, the ac power adapter and circuit board.
 
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.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7152759
MDR Text Key96010932
Report Number2938836-2017-35474
Device Sequence Number1
Product Code DRG
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 12/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEX1150
Other Device ID Number05414734504799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
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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