BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM

    MDR report key: 196986 · Received November 13, 1998

    Report

    Report Number
    2021898-1998-00139
    Event Type
    Injury
    Date Received
    November 13, 1998
    Date of Event
    September 9, 1998
    Report Date
    October 13, 1998
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAS EXPERIENCED THREE INSTANCES OF CATHETER FRACTURE IN APPROX THE SAME AREA OF PERITONEAL CATHETER (1 CM BELOW VALVE). THIS CATHETER WAS IMPLANTED ON 4/16/97 AND EXPLANTED ON 9/9/98. (SEE ALSO 2021898-1998-00137, -00138.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM Implant CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention