BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32 PLATINUM CONTACTS

    MDR report key: 1000648 · Received February 15, 2008

    Report

    Report Number
    9612007-2008-00005
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    GYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION, 311 ENTERPRISE DRIVE, PLAINSBORO, NJ 08536, ATTN: CORPORATE COMPLAINT COORDINATOR.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED, THAT THE WIRES FOR THE TWO LEADS LOCATED ON THE 32 CONTACT GRID SNAPPED PREVENTING HIM FROM RECORDING ANY ADDITIONAL DATA FROM THIS SECTION OF THE GRID. THE ELECTRODE WAS IN THE PT FOR 5 DAY FOR OBSERVATION AND THERE WERE NO SEIZURES RECORDED DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 32 PLATINUM CONTACTS ELECTRODES GYC INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1