BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 4893527 · Received July 6, 2015

    Report

    Report Number
    1627487-2015-07358
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    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
    OTHER

    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

    IT WAS REPORTED THE PATIENT EXPERIENCED A STABBING PAIN WITH STIMULATION ON. AN IMPEDANCE CHECK SHOWED HIGH IMPEDANCES ON ALL CONTACTS. AS A RESULT, THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED. THE ISSUE HAS BEEN RESOLVED BY SURGICAL INTERVENTION. THE PATIENT HAD TWO LEADS FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435153 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3410881

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other MODEL: 3716, SCS IPG| MODEL: 1192 (X2), SCS ANCHORS