BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 2140932 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-00846
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 5. REF MFR REPORT #S 1627487-2011-00845, 1627487-2011-00847, 1627487-2011-00848 AND 1627487-2011-00849.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 90 CM SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3169 172082

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention