BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 5142374 · Received October 10, 2015

    Report

    Report Number
    1627487-2015-05524
    Event Type
    Injury
    Date Received
    October 10, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 18, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S EVALUATION: THE COMPLAINT OF INFECTION CANNOT BE CONFIRMED VIA LABORATORY TESTING. (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 2 OF 4: REFERENCE MFR. REPORT#: 1627487-2015-05523; REFERENCE MFR. REPORT#: 1627487-2015-05525; REFERENCE MFR. REPORT#: 1627487-2015-05526.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673766 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 5115956

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other