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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD MERLIN AT HOME RF; PACEMAKER DATA TRANSMITTER
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ST. JUDE MEDICAL, INC., CRMD MERLIN AT HOME RF; PACEMAKER DATA TRANSMITTER Back to Search Results
Model Number EX1150C
Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/02/2015
Event Type  malfunction  
Event Description
It was reported that the transmitter exhibited a burning smell.The device did not function anymore; a malfunction was suspected.No further information could be obtained.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.(b)(4).
 
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Brand Name
MERLIN AT HOME RF
Type of Device
PACEMAKER DATA TRANSMITTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jennie hamel
15900 valley view court
sylmar, CA 91342
8184933462
MDR Report Key4752676
MDR Text Key17582412
Report Number2017865-2015-04501
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEX1150C
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/04/2015
Initial Date FDA Received05/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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