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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 Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The insulation of the power cable was melted due to a short circuit.
 
Manufacturer Narrative
Manufacturer date should be dec 7, 2012 rather than blank.
 
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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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5926659
MDR Text Key54477489
Report Number2017865-2016-05793
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEX1150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received07/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age21 YR
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