BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDUCTOS

    MDR report key: 2311810 · Received October 27, 2011

    Report

    Report Number
    1030489-2011-01381
    Event Type
    Death
    Date Received
    October 27, 2011
    Date of Event
    July 14, 2011
    Report Date
    September 30, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510600, PMA # P000058 WAS CLEARED IN THE UNITED STATES. NEITHER THE PRODUCT NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS PRODUCT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A VENTRO-DORSAL REFUSION STABILISATION SURGERY AT L5-S1 WITH IMPLANTATION OF RHBMP-2/ACS DUE TO PSEUDOARTHROSIS. IMMEDIATELY POST-OPERATIVELY THE PATIENT DEVELOPED A PARALYTIC ILEUS. FIVE DAYS POST-OPERATIVELY THE PATIENT UNDERWENT ABDOMINAL RELAPAROSCOPY WITHOUT ANY PATHOLOGICAL FINDINGS (NO LESION, NO INFECTION). IN THE DAYS FOLLOWING, THE PATIENT DEVELOPED SYSTEMIC SEPSIS WITH RENAL INSUFFICIENCY. THE PATIENT'S GENERAL CONDITION STABILIZED, AND THE PATIENT WAS IN RECONVALESCENCE AND MOBILIZATION. FIFTYONE DAYS POST-OPERATIVELY THE PATIENT EXPERIENCED CARDIAC ARREST AND WAS REANIMATED BUT DIED WITH HYPOXIC BRAIN DAMAGE. CAUSE OF DEATH WAS CARDIAC ARREST AND HYPOXIC BRAIN DAMAGE AFTER REANIMATION. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUCTOS NEK MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death UNKNOWN INTERBODY DEVICE