BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2 VALVE, REGULAR

    MDR report key: 3821115 · Received May 20, 2014

    Report

    Report Number
    2021898-2014-00164
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF THE VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD A DECOMPRESSIVE CRANIECTOMY AND INTRACRANIAL HEMATOMA SURGERY DUE TO CEREBRAL HEMORRHAGE CAUSED BY TRAUMA. ACCORDING TO THE REPORT, THE PATIENT WAS FALLING DOWN DUE TO SEIZURES. THE REPORT STATED THAT THE PATIENT WAS SENT TO THE HOSPITAL AND SHUNT IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2014. REPORTEDLY, THE VALVE PRESSURE WAS SET AT 1.0 DURING SURGERY. ACCORDING TO THE REPORT, AFTER THE SURGERY, THE DOCTOR FOUND THAT THE PATIENT¿S BRAIN CHAMBER HAD COLLAPSED. THE REPORT STATED THAT THE DOCTOR CHANGED THE VALVE PRESSURE TO 2.0; HOWEVER, THE PATIENT¿S HYDROCEPHALUS SYMPTOMS INCREASED. REPORTEDLY, THE DOCTOR THEN SET THE VALVE PRESSURE TO 1.0 OR 1.5. ACCORDING TO THE REPORT, THE PATIENT¿S SYMPTOMS STILL REMAINED AND THE PATIENT HAD SEIZURES INTERMITTENTLY. THE REPORT STATED THAT THE PATIENT COULDN'T SPEAK CLEARLY AND WAS EXPERIENCING RIGHT LIMB MOVEMENT DISORDER PROGRESSIVELY. REPORTEDLY, PATIENT¿S SHUNT WAS EXPLANTED ON (B)(6) 2014. ACCORDING TO THE REPORT, DURING THE SURGERY, DOCTOR FOUND THAT THE END OF THE VALVE WAS BROKEN AND LEAKING. REPORTEDLY, THE SALES REP PERFORMED THE PATENCY TEST ON THE EXPLANTED VALVE AND FOUND THAT IT WAS PATENT. ACCORDING TO THE REPORT, THE WHEN THE SALES REP PRESSED THE RESERVOIR, HE NOTICED LEAKAGE BETWEEN THE DELTA CHAMBER AND THE CONNECTOR. REPORTEDLY, THE PATIENT CONDITION IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298447 STRATA 2 VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D47261

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| R