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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 Wireless Communication Problem (3283)
Patient Problem Death (1802)
Event Type  Malfunction  
Event Description

During a follow-up, a loss of wireless communication on the device during high voltage (hv) therapy was noted; therefore, the user was unable to deactivate the high voltage therapy. It is noted the therapies being delivered were appropriate. The patient expired in (b)(6) 2016 due to comorbidities unrelated to the device or programmer. Related manufacturer report number: 2017865-2017-31633.

 
Manufacturer Narrative

The merlin programmer was returned and the inability to interrogate was confirmed. Inspection of the device revealed pepin board failure.

 
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Brand NameMERLIN PROGRAMMER
Type of DevicePACEMAKER 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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key6893495
MDR Text Key87388415
Report Number2017865-2017-32325
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberP030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3650
OTHER Device ID Number05414734500661
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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