BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2885042 · Received December 18, 2012

    Report

    Report Number
    1627487-2012-06961
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 26, 2012
    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 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 3. REFERENCE MFR REPORT NUMBERS: 1627487-2012-06956 AND 1627487-2012-06962. ON (B)(6) 2012, THE PT UNDERWENT A TRIAL PROCEDURE. ON (B)(6) 2012, THE PT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO EXPERIENCING FEVER, VOMITING, AND ABDOMINAL/BACK PAIN A DAY PRIOR. AS A RESULT, THE LEADS WERE REMOVED. AN MRI WAS PERFORMED THE NEXT DAY AND REVEALED AN EPIDURAL ABSCESS. THE PT HAD A DECOMPRESSION ON THE AREA OF THE ABSCESS, BUT THE PT IS DOING BETTER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3046 3439205

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R