BEUDAMED
    FDA Adverse Event Summary report: N

    3X3 DUREPAIR DURA SUBSTITUTE

    MDR report key: 974928 · Received July 24, 2007

    Report

    Report Number
    2021898-2007-00145
    Date Received
    July 24, 2007
    Date of Event
    January 10, 2007
    Report Date
    June 26, 2007
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K041000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR RETURN TO THE MFR. THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. THIS WAS THE ONLY REPORT OF INFECTION FROM LOT NUMBER 060837. A CHECK OF THE MFG AND STERILIZATION RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED A POST-OPERATIVE INFECTION AFTER HAVING A SUBOCCIPITAL CRANIOTOMY FOR LESION RESECTION. THE PT UNDERWENT LEFT RETROSIGMOID EXCISION OF AN ACOUSTIC NEUROMA. ONE MONTH LATER SHE DEVELOPED WOUND DRAINAGE. THE MONTH AFTER DRAINAGE WAS DISCOVERED; IT INCREASED A GREAT DEAL, WHICH REQUIRED RE-ADMISSION TO THE HOSPITAL THE FOLLOWING MONTH (FOUR MONTHS AFTER THE INITIAL SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3X3 DUREPAIR DURA SUBSTITUTE GXQ GXQ MEDTRONIC NEUROSURGERY NA 060837

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR