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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; PACEMAKER PROGRAMMER
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) MERLIN PROGRAMMER; PACEMAKER PROGRAMMER Back to Search Results
Model Number 3650
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 06/23/2015
Event Type  malfunction  
Event Description
It was reported that during a device check, the programmer made an audible pop sound and the screen went black.The programmer also exhibited a burning smell.The device was rebooted and normal function resumed.The device remained in the field.
 
Manufacturer Narrative
(b)(4).
 
Event Description
New information notes the programmer was returned for evaluation.
 
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Brand Name
MERLIN PROGRAMMER
Type of Device
PACEMAKER PROGRAMMER
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
MDR Report Key4883339
MDR Text Key6019632
Report Number2017865-2015-26536
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/23/2015
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 Number3650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2015
Initial Date FDA Received07/01/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received07/31/2015
12/22/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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