BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR DURA REGENERATION MATRIX, 2" X 2"

    MDR report key: 5115505 · Received September 30, 2015

    Report

    Report Number
    2021898-2015-00370
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 31, 2015
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K063117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE NOTE THAT REJECTION/FOREIGN BODY REACTION IS A GENERAL RISK OF DURA-RELATED SURG ERY. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE ALSO CAUTION THAT THE FOREIGN BODY RESPONSE ASSOCIATED WITH THE USE OF SEALANTS AND HEMOSTATIC AGENTS IN CONJUNCTION WITH DUREPAIR MAY BE MORE PRONOUNCED THAN USE OF DUREPAIR ALONE. THIS RESPONSE MAY INCREASE THE INCIDENT RATES OF KNOWN RISKS OF DURA SUBSTITUTES (INCLUDING CSF LEAKS), PARTICULARLY IN HIGH PRESSURE GRADIENT APPLICATIONS. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2015 DUE TO CHIARI DECOMPRESSION. ACCORDING TO THE REPORT, WITHIN A FEW DAYS THE PATIENT WAS EXPERIENCING COMPLICATIONS CONSISTING OF FEVER AND FLUID COLLECTION. IT WAS REPORTED THE SURGICAL PROCEDURE WAS A CRANIOTOMY. IT WAS ALSO REPORTED THE DEVICE WAS SUTURED WITH A 4.0 SILK AND A VALSALVA WAS PERFORMED AT IMPLANTATION, WITH NO LEAK OBSERVED. THE REPORT STATED ANTIBIOTICS WERE USED WITH THE PATIENT AND THE PATIENT WAS MONITORED AND TESTED NEGATIVE FOR MENINGITIS. REPORTEDLY, THE DEVICE REMAINS IMPLANTED AND THE PATIENT IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644847 DUREPAIR DURA REGENERATION MATRIX, 2" X 2" DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY 1412015

    Patients

    Seq Age Sex Outcome Treatment
    1 00006 YR Required Intervention