BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4143191 · Received September 22, 2014

    Report

    Report Number
    1627487-2014-02673
    Event Type
    Injury
    Date Received
    September 22, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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

    DEVICE 2 OF 2 REFERENCE MFR REPORT#: 1627487-2014-02672. THE PATIENT RECEIVED TWO SCS LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT HAD HIS SCS SYSTEM EXPLANTED SEVERAL MONTHS AFTER HE WAS IMPLANTED. THE REASON FOR THE EXPLANT IS UNDETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587792 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3181 56822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other