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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR); PACEMAKER PROGRAMMER
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR); PACEMAKER PROGRAMMER Back to Search Results
Model Number 3650
Device Problems Thermal Decomposition of Device (1071); Charred (1086)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2018
Event Type  malfunction  
Event Description
It was reported that the merlin programmer stopped working.The screen went black and was smoking from the case.The device was returned and replaced.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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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
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7223512
MDR Text Key98427948
Report Number2017865-2018-01559
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3650
Device Catalogue Number3650
Other Device ID Number05414734500661
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2008
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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