BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 4428377 · Received January 16, 2015

    Report

    Report Number
    1226348-2015-10042
    Event Type
    Injury
    Date Received
    January 16, 2015
    Date of Event
    January 8, 2015
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. NO ROOT CAUSE COULD BE DETERMINED AS NO SAMPLE WAS RETURNED. 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. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE REPORT FROM HMT FOUND THAT: THE TRANSMITTER HAS BEEN RETURNED IN A VERY DIRTY STATE AND THE TRANSMITTER COVER IS BROKEN DUE TO BAD HANDLING. THE VPV PROGRAMMER WAS VERIFIED. 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

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP WILL BE FILED AFTER COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY TH REP THAT THE PROGRAMMER FAILED TO ADJUST PROGRAMMABLE VALVE TO DESIRED LEVEL AFTER MULTIPLE ATTEMPTS (6+ ATTEMPTS) COULD NOT LOWER THE PRESSURE OF PATIENTS VALVE AS NEEDED. LOANER VPV ISSUED SAME DAY, PATIENT TO BE REPROGRAMMED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39543 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention