BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC

    MDR report key: 3162396 · Received June 6, 2013

    Report

    Report Number
    1627487-2013-15774
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD RECEIVED A LOW BATTERY FLAG, AND THE IPG WAS NO LONGER PROVIDING STIMULATION. THE SJM REPRESENTATIVE CLEARED THE FLAG, BUT IT RETURNED. THE PATIENT STATED, HE HAS NOT USED HIS SCS SYSTEM IN APPROXIMATELY 1 YEAR DUE TO HIS PAIN IMPROVING. HOWEVER, THE PATIENT NOW DESIRES TO RESUME THE USE OF HIS SCS SYSTEM. THE PATIENT HAS NOT YET DECIDED IF HE WISHES TO PURSUE SURGICAL INTERVENTION AT A LATER DATE TO HAVE HIS IPG EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251626 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3439170

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| SCS LEAD, MODEL 3186 (2)