BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4151858 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-12653
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE PATIENT HAD 2 LEADS WITH THE SAME LOT. IT WAS REPORTED (UNITED KINGDOM) THE PATIENT LOST STIMULATION SEVERAL MONTHS AGO. REPROGRAMMING DID NOT RESOLVE THE ISSUE. DIAGNOSTIC TESTING REVEALED NO LEAD ANOMALIES. X-RAYS WERE TAKEN AND REVEALED THE LEADS HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEADS. NOTE THE PATIENT'S LEADS WERE PLACED PERIPHERAL, AROUND THE HIPS (OFF-LABEL USE). POST OPERATIVE THE PATIENT REPORTED RECEIVING EFFECTIVE STIMULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623245 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3186 3652586

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other