BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VPV PROGRAMMER PLUS TRANSMIT JPN

    MDR report key: 15495650 · Received September 27, 2022

    Report

    Report Number
    3013886523-2022-00442
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Report Date
    November 8, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE VPV PROGRAMMER WAS RETURNED FOR EVALUATION: DHR - THE LOT MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE CUSTOMER¿S INDICATION OF ERROR IS CONFIRMED. THIS IS DUE TO A DEFECTIVE POWER MODULE AND PROGRAMMER BOX BOTTOM, WHICH MUST BE REPLACED. THE TRANSMITTER COIL FEET ARE BROKEN AND NEED REPLACEMENT. THE RESET, SAFETY AND FUNCTIONAL TEST MUST BE PERFORMED. REPAIR PERFORMED WITH RESET, SAFETY AND FUNCTIONAL TEST. ROOT CAUSE - THE ROOT CAUSES OF THE PROBLEMS WERE PROBABLY DUE TO NORMAL WEAR OUT (AS THE DEVICE IS OLDER THAN 15 YRS).

    Description of Event or Problem · 0

    A FACILITY REPORTED BURNING SMELL WHEN PLUGGING THE PROGRAMMER (ID 823192) IN AN ELECTRIC OUTLET AFTER CHANGING A SHUNT VALVE SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951170 VPV PROGRAMMER PLUS TRANSMIT JPN VPV SYSTEM JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown