BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV PROGRAMMER REVISED

    MDR report key: 12512803 · Received September 22, 2021

    Report

    Report Number
    3013886523-2021-00401
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Report Date
    February 15, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    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

    THE CODMAN PROGRAMMER (ID 823192R) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR): THE PRODUCT 823192R FOR SERIAL NUMBER (B)(6) (LOT # 4042694), AND THE LOT MET SPECIFICATIONS WHEN RELEASED FAILURE ANALYSIS: THE INSPECTION IN INTEGRA USA HAS NO REPORTED ERROR MESSAGE ISSUE. DEVICE HAS BEEN RESET, CHECKED AND RETURNED TO CUSTOMER. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD NOT BE DETERMINED AS THE DEVICE WORKED CORRECTLY. HOWEVER, THE POSSIBLE ROOT CAUSE FOR THIS ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO A TECHNICAL PROBLEM OF THE SYSTEM OR TO PROGRAMMER/TRANSMITTER MALFUNCTION, VALVE MALFUNCTION.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A FACILITY REPORTED A VPV PROGRAMMER WASN¿T RECEIVING CONFIRMATIONS AND IT WAS OVERHEATING AFTER USING MULTIPLE TIMES. NO PATIENT INJURY REPORTED AND IT IS UNKNOWN IF THE EVENT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409863 CODMAN VPV PROGRAMMER REVISED VPV SYSTEM JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4042694

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown