BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITONEAL CATHETER, STANDARD, 90 CM

    MDR report key: 8383579 · Received March 1, 2019

    Report

    Report Number
    2021898-2019-00084
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169497122
    PMA / PMN Number
    K792005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED AND CAPTURED UNDER REGULATORY REPORTS 2021898-2019-00278 AND 2021898-2019-00279. ANY FURTHER INFORMATION FOR THE EVENT WILL BE REPORTED UNDER THE REFERENCED REPORTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SEEN RAPID OBSTRUCTIONS DUE TO GRAPHITE GRANULOMAS AT THE DISTAL ENDS OF THE PERITONEAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175633 PERITONEAL CATHETER, STANDARD, 90 CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 43522 E42443 00643169497122

    Patients

    Seq Age Sex Outcome Treatment
    1