BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3134043 · Received May 23, 2013

    Report

    Report Number
    1627487-2013-02711
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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

    EVALUATION 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 RELATED TO THIS EVENT 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 INFORMATION 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 3 OF 4. REFERENCE MFR REPORTS: 1627487-2013-02709, 02710 AND 02712. IT WAS REPORTED THE PT HAD HER SYSTEM EXPLANTED DUE TO A (B)(6) INFECTION. THE PT STATED HER EXPLANT DATE WAS (B)(6) 2012. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. AS THE LOCATION OF THE INFECTION IS UNK, ALL KNOWN DEVICES ARE BEING REPORTED. THE PT HAS TWO ANCHORS FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229986 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3163 3734227

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R