BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRW PRECISION ARC SYSTEM

    MDR report key: 2573038 · Received May 9, 2012

    Report

    Report Number
    1222895-2012-00012
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    April 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE TRUNION LOCK OF A CRWPRECISE SEIZED AND WOULD NOT RELEASE THE CLUTCH DURING A DEEP BRAIN STIMULATOR IMPLANTATION. THE CUSTOMER CONFIRMED THAT THE PT DID NOT INCUR AN INJURY, HOWEVER THE PT WAS ANESTHETIZED WHEN THE PROBLEM OCCURRED. THE DOCTOR HAD TO MANUALLY FORCE THE ARC INTO THE CORRECT "RING" POSITION AFTER DETERMINING THE CAUSE OF THE MALFUNCTION WHICH WAS A MECHANICAL PROBLEM. NO EXTRAORDINARY MEDICAL INTERVENTION WAS REQUIRED AND AT NO TIME WAS THE PT IN DANGER. THE MECHANICAL PROBLEM ADDED APPROXIMATELY 20 MINUTES TO THE SURGICAL PROCEDURE. THE STEREOTACTIC DEEP BRAIN STIMULATOR IMPLANTATION OUTCOME/CURRENT STATUS - PT'S DEEP BRAIN STIMULATION WAS SUCCESSFUL AND THE STATUS/RESULT IS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRW PRECISION ARC SYSTEM STEREOTAXY HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1