BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM

    MDR report key: 3237840 · Received July 17, 2013

    Report

    Report Number
    2021898-2013-00236
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K951258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING THE CATALOG AND LOT NUMBER OF THE DEVICE WAS RECEIVED BY MEDTRONIC NEUROSURGERY. APPROXIMATELY 11.5 CM OF THE VENTRICULAR CATHETER WAS RETURNED. THERE WAS PROTEINACEOUS DEBRIS OBSERVED IN THE INTERIOR AND EXTERIOR OF THE CATHETER. THE RETURNED CATHETER MET THE SPECIFICATIONS FOR PATENCY AND LEAK TESTING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    APPROX 11.5 CM OF THE VENTRICULAR CATHETER WAS RETURNED. THERE WAS PROTEINACEOUS DEBRIS OBSERVED IN THE INTERIOR AND EXTERIOR OF THE CATHETER. THE RETURNED CATHETER MET THE SPECS FOR PATENCY AND LEAK TESTING. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE OPERATION, THE DEVICE WAS FOUND TO BE LEAKING. ACCORDING TO THE REPORT, A NEW DEVICE WAS USED. THE REPORTER STATED THAT THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331707 VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D32856

    Patients

    Seq Age Sex Outcome Treatment
    1