BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2 VALVE, REGULAR

    MDR report key: 3130090 · Received May 21, 2013

    Report

    Report Number
    2021898-2013-00186
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FOLLOW-UP WITH THE PHYSICIAN'S OFFICE, IT WAS DISCOVERED THAT THE PATIENT HAD NOT VISITED THE PHYSICIAN AFTER THE IMPLANTATION OF THE VALVE. ACCORDING TO NURSE KELLY VECCHIARELLI AT KECK SCHOOL OF MEDICINE - USC, SINCE THE PATIENT HAD NOT COME IN TO BE EXAMINED, THERE WAS NO WAY TO FIND OUT IF THE PATIENT'S SYMPTOMS HAD ANYTHING TO DO WITH THE SHUNT. THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD A RUPTURED CEREBRAL ANEURYSM AFTER WHICH SHE DEVELOPED HYDROCEPHALUS. ACCORDING TO THE REPORT, THE PATIENT HAD BEEN TAKING PREDNISOLONE FOR JOINT INFLAMMATION. THE REPORT STATED THAT THE PATIENT'S ABDOMEN WAS DISTENDED AT A LOCATION WHERE THE END OF THE PERITONEAL CATHETER WAS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225184 STRATA 2 VALVE, REGULAR JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D34388

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR