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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. MERLIN PROGRAMMER; PACEMAKER PROGRAMMER
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ST. JUDE MEDICAL, INC. MERLIN PROGRAMMER; PACEMAKER PROGRAMMER Back to Search Results
Model Number 3650
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2018
Event Type  malfunction  
Event Description
Following service, when the programmer was plugged in, sparks were observed followed by a burn odor.The programmer will be replaced to resolve the event.There were no adverse consequences to patient or user.
 
Manufacturer Narrative
Programmer sparking upon start up was confirmed upon analysis.Troubleshooting revealed psu (power supply unit) as the root-cause for this issue.The field complaint of power up anomaly was verified as the event could be reproduced.
 
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Brand Name
MERLIN PROGRAMMER
Type of Device
PACEMAKER PROGRAMMER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7624990
MDR Text Key111875945
Report Number2017865-2018-08608
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3650
Device Catalogue Number3650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/22/2018
Was Device Evaluated by Manufacturer? Yes
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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