BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 4957056 · Received July 31, 2015

    Report

    Report Number
    1226348-2015-10436
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 7, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CLINICIAN ATTEMPTED TO REPROGRAM CHPV TO 130MM IN CLINIC SETTING AFTER MRI. WAS UNABLE TO DO SO AND TOOK THE PATIENT TO FLUOROSCOPY TO OBTAIN AN IMAGE. VALVE WAS SET AT 90MM. USED VPV TO RESET TO 130MM AND RECEIVED AUDIO VERIFICATION AND PROGRAMMING COMPLETE MESSAGE. HOWEVER, FLUORO INDICATED THE VALVE WAS STILL AT 90MM. PROCESS REPEATED WITH 2ND VPV AND AUDIO VERIFICATION WAS RECEIVED AND PROGRAMMING COMPLETE MESSAGE. FLUORO IMAGING AGAIN INDICATED THE VALVE WAS SET TO 90MM. I WAS CALLED AND WENT TO THE HOSPITAL TO SUPERVISE AND TROUBLE SHOOT. THE CLINICIAN ATTEMPTED TO REPROGRAM AGAIN WITH BOTH VPV UNITS AND DID NOT GET AUDIO VERIFICATION AND RECEIVED THE REPEAT ADJUSTMENT PROMPT. UNDER FLUORO THE VALVE WAS STILL AT 90MM. I RECHECKED VALVE UNDER FLUORO AND REMARKED THE PATIENT. THE CLINICIAN THEN UTILIZED MY VPV PROGRAMMER AND TRIED TO SET AT 130MM. WE DID NOT RECEIVE AUDIO VERIFICATION AND GOT THE REPEAT ADJUSTMENT MESSAGE. HOWEVER, FLUORO IMAGING INDICTED THE VALVE WAS SET AT 130MM. PATIENT WAS RELEASE. I HAVE TAKEN BOTH THE PROGRAMMERS OUT OF THE HOSPITAL AND LET THEM WITH MY VPV. VALVE HAS BEEN IMPLANTED FOR APPROXIMATELY 1 YEAR AND APPEARS TO ME FUNCTIONING NORMALLY._TWO CLINICIANS AND THE RADIOLOGIST HAVE VERIFIED THAT THEY RECEIVED THE ADJUSTMENT COMPLETE FROM THE DEVICE AND THE IMAGE WAS INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499765 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention