BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM

    MDR report key: 144763 · Received January 16, 1998

    Report

    Report Number
    2021898-1998-00006
    Event Type
    Injury
    Date Received
    January 16, 1998
    Date of Event
    December 13, 1997
    Report Date
    December 15, 1997
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CATHETERS HAVE FRACTURED BELOW SUTURE TWICE. FIRST IMPLANTED ON 7/25/1995 AND REVISED ON 7/9/1996. THE SECOND FRACTURE OCCURRED ON 12/13/1997. CATHETERS HAVE FRACTURED BELOW SUTURE TWICE. FIRST CATHETER WAS IMPLANTED ON 7/25/1995 AND REVISED ON 7/9/1996. A NEW CATHETER WAS INSERTED BUT THE FIRST CATHETER WAS NOT REMOVED AT THE TIME. WAS INITIALLY REPORTED ON 7/19/1996, PC1595. THE SECOND FRACTURE OCCURRED ON 12/13/1997. AT THE TIME, THE DR WAS ABLE TO RETRIEVE BOTH CATHETERS.

    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 J2946

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention