BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3142839 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-08146
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2012
    Report Date
    May 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-08145. IT WAS REPORTED, THE PT HAD NEITHER USED NOR RECHARGED THE SCS SYSTEM FOR APPROX 18 MONTHS. PT ALSO STATED, THE SYSTEM DID NOT RELIEVE THE PAIN DESPITE THE REPROGRAMMING ATTEMPTS. HENCE, THE PT HAD RECEIVED AN EPIDURAL INJECTION IN (B)(6) 2011 AND DID NOT HAVE PAIN SINCE THEN. F/U INFO SUGGESTED THE PT WAS TO MAKE AN APPOINTMENT WITH THE PHYSICIAN FOR POSSIBLE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232356 LAMITRODE TRIPOLE 16C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 118521

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR