BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER PORTNOY VENTRICULAR STRIPED

    MDR report key: 446166 · Received March 4, 2003

    Report

    Report Number
    2648988-2003-00005
    Event Type
    Malfunction
    Date Received
    March 4, 2003
    Report Date
    March 3, 2003
    Manufacturer
    INTEGRA NEUROSCIENCES INC.
    Product Code
    HCA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN ONE CASE THE CATHETER BROKE BELOW THE VALVE SIX MONTHS AFTER IMPLANTATION. NO FURTHER INFO IS AVAILABLE. ADDITIONAL INFO WAS REQUESTED ON 02-19-2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER PORTNOY VENTRICULAR STRIPED CSF CATHETERS HCA INTEGRA NEUROSCIENCES INC. * 1940129

    Patients

    Seq Age Sex Outcome Treatment
    1 *