BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK DEVICE

    MDR report key: 1061015 · Received June 12, 2008

    Report

    Report Number
    3003418325-2008-00013
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 21, 2008
    Report Date
    June 12, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE SPECIFIC DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN IDENTIFIED AND RETURN OF THE SUSPECT DEVICE FOR EVAL IS NOT EXPECTED. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A PT'S DAUGHTER CONTACTED THE COMPANY STATING THAT HER MOTHER HAS HAD SEVERAL NEUROSURGICAL PROCEDURES. IN 2007, A SHUNT WAS PLACED. IN 2008, SHE HAD A SECOND SURGICAL PROCEDURE DURING WHICH A SHUNT WAS PLACED. THE FOLLOWING MONTH, SHE HAD SURGERY TO ADDRESS EXCESSIVE CEREBROSPINAL FLUID LEAKAGE. AFTER THIS PROCEDURE, THE SURGEON STATED THAT AN "INTEGRA PATCH" THAT HAD BEEN IMPLANTED DURING THE SURGICAL PROCEDURE IN 2008 HAD "DISINTEGRATED". THE BRAND NAME OF THE DEVICE IS UNK. REPEATED ATTEMPTS WERE MADE BY A TELEPHONE AND IN A LETTER DELIVERED BY CERTIFIED MAIL TO DETERMINE THE IDENTIFY OF THE DEVICE. THE PHYSICIANS DECLINED TO PROVIDE INFO CITING HIPAA (HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT) COMPLIANCE. THE REPORTER IS SEEKING TO OBTAIN HEALTH RECORDS PERTINENT TO THE EVENT SO THAT THE PRODUCT IDENTITY CAN BE KNOWN BUT NO INFO HAS BEEN RECEIVED TO DATE. THE PT IS NOW LIVING AT HOME AND HER MEDICAL CONDITION IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEVICE DURAGEN GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHUNT PLACEMENT