BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3141590 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-13802
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 14, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-13801. THE PT HAD TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS DISSATISFIED WITH HIS SCS SYSTEM AND IT WAS EXPLANTED APPROXIMATELY 2 1/2 MONTHS AGO. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232693 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3597925

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention