BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3192059 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02882
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. THE INDIVIDUAL AFFECTED DEVICE WAS REMOVED FROM THE LOT. ALL OTHER DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 4 OF 4. REF MFR REPORTS: 1627487-2013-02879, 1627487-2013-02880 AND 1627487-2013-02881.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281030 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3543278

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION, MODEL 3346 (2)| SCS IPG, MODEL 3788