BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3961364 · Received July 18, 2014

    Report

    Report Number
    1627487-2014-24027
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    February 17, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2014-24028. PT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS INVOLVED IN MOTOR VEHICLE ACCIDENT, SUBSEQUENTLY, THE PT EXPERIENCED UNWANTED LEGS/ABDOMEN STIMULATION. REPROGRAMMING WAS UNSUCCESSFUL. X-RAYS REVEALED LEAD MIGRATION. PRIOR TO THE MOTOR VEHICLE ACCIDENT, IT WAS REPORTED THE PT EXPERIENCED PAIN AT THE ANCHOR SITE. AS PER SJM REP, THERE IS A KNOTTED/RAISED AREA AT THE ANCHOR SITE WITH A FORMED SCAR TISSUE. SURGICAL INTERVENTION WILL TAKE PLACE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421219 OCTRODE SC SLEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4265386

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788