BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 6794980 · Received August 15, 2017

    Report

    Report Number
    1226348-2017-10611
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOTH 510(K) #'S ASSOCIATED WITH THIS DEVICE: K061876 & K050739. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    . THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT WAS RECEIVED IN (B)(4) ON AUGUST 16TH, 2017. THE PRODUCT WAS TESTED IN CODMAN (B)(4) AND IT WAS REPORTED THAT THE TRANSMITTER HEAD WAS TOTALLY DAMAGED. THE ISSUE WAS CONFIRMED. THE DEVICE WAS FORWARDED TO OUR SUPPLIER (B)(4): THE INVESTIGATION AT THE SUPPLIER DETECTED THAT THE COMPLETE TRANSMITTER WAS DAMAGED. THE COMPLETE TRANSMITTER WAS REPLACED (SEE REPORT FROM (B)(4) FOR MORE INFORMATION). THE DEVICE WILL BE SHIPPED BACK TO THE CUSTOMER. AS THE ISSUE WAS RELATING TO A USER ERROR, NO DHR REVIEW WAS PERFORMED FOR THE PROGRAMMER 82-3192, SN # (B)(4), (LOT # CLHBB5). THE ROOT CAUSES OF THE PROBLEM WERE DUE TO A BAD HANDLING. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    REP WAS CONTACTED BY THE NEURO REGISTRAR WHO WAS TRYING TO PROGRAM A HAKIM VALVE IN A PATIENT. THE HEAD OF THE VPV PROGRAMMER WAS HEATING UP AND A MESSAGE CONTINUED TO DISPLAY THAT ADJUSTMENT WAS INCOMPLETE. REP ATTENDED THIS CASE AT THE REQUEST OF THE REGISTRAR AND WHEN SHE LOOKED AT THE VPV PROGRAMMER SHE NOTICED THE HEAD WAS QUITE WARM AND DAMAGED WITH CRACKS TO THE CASING AND THE PLASTIC COVERING THE PRONGS WAS ALSO DAMAGED. NO ADVERSE REACTION TO THE PATIENT. NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575813 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CLHBB5

    Patients

    Seq Age Sex Outcome Treatment
    1