BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-LUMBOPERITONEAL SHUNT

    MDR report key: 76266 · Received March 12, 1997

    Report

    Report Number
    2021898-1997-00017
    Event Type
    Injury
    Date Received
    March 12, 1997
    Report Date
    February 11, 1997
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED TO MEDTRONIC PS MED CO WAS UNABLE TO CONFIRM OR CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED COMPLAINT. THE MFG RECORDS FOR THE PRODUCT WERE REVIEWED AND NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    PT INTERMITTENTLY COMPLAINED AFTER INSERTION OF A LUMBOPERITONEAL SHUNT THAT THE PRESSURE BUILDS UP IN THE HEAD, SOMETHING OPENS AND THEN SHE OVERDRAINS AND DEVELOPS LOW PRESSURE HEADACHES. THE SHUNT WAS REVISED. WHEN TESTED, THE PRODUCT HAD AN INITIAL HIGH RESISTANCE FOLLOWED BY A LOWER RESISTANCE WHEN FLUID BEGAN TO FLOW. THIS RESERVOIR WAS IRRETRIEVABLY DAMAGED DURING FURTHER MANIPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-LUMBOPERITONEAL SHUNT Implant CENTRAL NERVOUS FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA H6407

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention