BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 5359768 · Received January 12, 2016

    Report

    Report Number
    1226348-2016-10039
    Event Type
    Injury
    Date Received
    January 12, 2016
    Date of Event
    December 21, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: MODEL #. DEVICE EVALUATION: EIGHT SECTIONS. UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT WAS RECEIVED IN (B)(4) THE 18TH JANUARY, 2016. THE PRODUCT WAS TESTED IN (B)(4) AND AN ISSUE WAS REPORTED (NOISE IN THE VPV). THE PRODUCT WAS FORWARDED TO OUR SUPPLIER (B)(4): THE INVESTIGATION ON THE SUPPLIER DETECTED THAT THE TRANSMITTER IS TOO OLD AND THAT THE FERRITE IS WELL NOT FIXED. TRANSMITTER COVER, TRANSMITTER SWITCH AND DOME PLUG HAS BEEN REPLACED AND THE FERRITE HAS BEEN RE-FIXED. A DHR REVIEW WAS PERFORMED FOR THE VPV PROGRAMMER 82-3192 S/N: (B)(4) (LOT#CJFDHD), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON MAY 20TH, 2008. THE ROOT CAUSE OF THE NOISE IN THE VPV IS DUE TO A NORMAL USE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHILE REPROGRAMMING THE HAKIM PROGRAMMABLE VALVE, THE UNIT CONTINUED TO OVER HEAT. IT BEGAN TO OVER HEAT FROM THE BEGINNING OF THE PROCEDURE. STAFF USED SAME LIKE UNIT TO CONTINUE WITH NO FURTHER ISSUES. DELAY 1 HOUR. REPROGRAMMING IS USUALLY CARRIED OUT AT THE WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20810 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CJFDHD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention