BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULO-PERITONEAL SHUNT

    MDR report key: 9511 · Received July 21, 1994

    Report

    Report Number
    9511
    Event Type
    Malfunction
    Date Received
    July 21, 1994
    Date of Event
    May 15, 1994
    Report Date
    May 15, 1994
    Manufacturer
    CORDIS
    Product Code
    LID
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A NEUROSURGEON REMOVED THE SHUNT FROM THE PATIENT. DURING THE PROCEDURE, THE NEUROSURGEON NOTICED THAT THE SHUNT WAS LEAKING VIA A CRACK BEHIND ONE OF THE VALVES.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULO-PERITONEAL SHUNT LID CORDIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other