BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4132714 · Received September 29, 2014

    Report

    Report Number
    1627487-2014-21633
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). 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 # 1627487-2014-21646. THE PT RECEIVED TWO PERCUTANEOUS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED INTERMITTENT SHOCKING SENSATIONS. X-RAYS INDICATED A FRACTURE ON ONE OF THE LEADS. DIAGNOSTICS INDICATED MULTIPLE INVALID IMPEDANCES VALUES. REPROGRAMMING WAS UNSUCCESSFUL. ADDITIONALLY, THE PT STATED THE IPG WOULD RANDOMLY TURN ON/OFF. DUE TO THE REPORTED ISSUES, SURGICAL INTERVENTION WILL TAKE PLACE AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604985 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4298394

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other