BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VPV PROGRAMMER PLUS TRANSMIT JPN

    MDR report key: 10551035 · Received September 17, 2020

    Report

    Report Number
    3013886523-2020-00115
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Report Date
    May 5, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G1, G3, G6, H2, H3, H4, H6, H10 THE PROGRAMMER WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE LOT HISTORY RECORD FOR THE DEVICE 82-3192, SN V01480 (LOT # CFKBJ9) WAS REVIEWED FOR COMPLETENESS DURING THE RELEASE PROCESS TO INVENTORY. AT THAT TIME BASED ON THE FACT THAT NO DISCREPANCIES WERE NOTED FOR THE PRODUCTS BEING ACCEPTED, THEY WERE RELEASED TO STOCK. FAILURE ANALYSIS - INSPECTION CONFIRMED THE REPORTED ISSUE AS ERROR MESSAGE DISPLAYED. DEVICE HAS BEEN RESET, CHECKED AND FUNCTIONED CORRECTLY. THE ROOT CAUSE OF THE ERROR MESSAGE COULD OCCURRED IF THE TRANSMITTER IS DISCONNECTED DURING THE SELF TEST OR DUE TO MAINS SUPPLY PERTURBATION.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THE HAKIM PROGRAMMER WOULD NOT REPROGRAM THE VALVE OR GIVE CONFIRMATION. NO PATIENT INJURY/CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010017 VPV PROGRAMMER PLUS TRANSMIT JPN VPV SYSTEM JXG INTEGRA LIFESCIENCES SWITZERLAND SAR V01480

    Patients

    Seq Age Sex Outcome Treatment
    1