BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3192061 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02880
    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
    P010032
    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 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 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 4. REFERENCE MFR REPORTS: 1627487-2013-02879, 1627487-2013-02881 AND 1627487-2013-02882. IT WAS REPORTED THE PT DEVELOPED AN INFECTION AT HER LEAD SITE WHICH WAS CONFIRMED BY A CULTURE. CONSEQUENTLY, THE PHYSICIAN EXPLANTED ALL OF THE LEADS, BUT THE IPG AND EXTENSIONS REMAIN IMPLANTED. THE PT WAS TREATED WITH ORAL AND INTRAVENOUS ANTIBIOTICS, AND THE PT WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281635 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 3554654

    Patients

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