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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) MERLIN PROGRAMMER; PROGRAMMER, PACEMAKER Back to Search Results
Model Number 3650
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Patient Involvement (2645)
Event Date 04/13/2020
Event Type  malfunction  
Manufacturer Narrative
Final analysis found the inverter board overheated causing burn marks, which resulted in intermittent display on the screen.
 
Event Description
It was reported that the screen image on the programmer was intermittent.
 
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Brand Name
MERLIN PROGRAMMER
Type of Device
PROGRAMMER, PACEMAKER
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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
MDR Report Key10014027
MDR Text Key189477257
Report Number2938836-2020-02929
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734500661
UDI-Public05414734500661
Combination Product (y/n)N
Reporter Country CodeRQ
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
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3650
Device Catalogue Number3650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/13/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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