BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MEDTRONIC DUREPAIR

    MDR report key: 1691612 · Received May 14, 2010

    Report

    Report Number
    2021898-2010-00091
    Event Type
    Injury
    Date Received
    May 14, 2010
    Date of Event
    February 1, 2010
    Report Date
    April 22, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K041000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THESE REPORTABLE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE AND PT INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFORMATION ON INDIVIDUAL EVENTS. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE DESCRIBED POST-OPERATIVE CSF LEAKAGE RATE WAS WITHIN THE EXPECTED RANGE FOR DURAL GRAFTS. WEINSTEIN JS, LIU KC, DELASHAW JB, ET AL. THE SAFETY AND EFFECTIVENESS OF A DURAL SEALANT SYSTEM FOR USE WITH NONAUTOLOGOUS DURAPLASTY MATERIALS. J NEUROSURG 2000 FEBRUARY; 112:428-433.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A STUDY OF 66 RETROSPECTIVELY REVIEWED SUBJECTS WHICH RECEIVED A COMMERCIAL DURAPLASTY MATERIAL USED WITH COMMERCIAL DURAL SEALANT SYSTEM. UNSPECIFIED MEDTRONIC DUREPAIR, DURA REGENERATION MATRIX, WAS USED AS THE PURAPLASTY MATERIAL IN 9 OF THE 66 PTS. THE SOURCE LITERATURE REPORTED THAT POSTOPERATIVE CSF LEAKS OCCURRED IN 5 OF THE 66 SUBJECTS. ALL THESE LEAKS WERE TREATED AND RESOLVED WITH NO RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MEDTRONIC DUREPAIR GXQ MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R