BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 5039325 · Received August 28, 2015

    Report

    Report Number
    1627487-2015-23495
    Event Type
    Injury
    Date Received
    August 28, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 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

    (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.(B)(4).

    Description of Event or Problem · 1

    DEVICE 1 OF 2: REFERENCE MFR. REPORT#: 1627487-2015-23496. IT WAS REPORTED THE PATIENT HAS TWO LEADS ONE LEAD WAS UNABLE TO PROVIDE STIMULATION AND DIAGNOSITCS INDICATED HIGH AND LOW IMPEDANCE READINGS, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THEREAPY WAS RESTORED POSTOPERATIVE. PLEASE NOTE IT IS UNKNOWN WHICH OF THE PATIENT'S LEADS REFECTED THE IMPEDANCE ISSUES, THEREFORE, BOTH ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572304 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4956902

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other MODEL 3789, SCS IPG