BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON DIGITAL PREAMPLIFIER

    MDR report key: 3234088 · Received July 18, 2013

    Report

    Report Number
    1045254-2013-00463
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY THE QUALITY ENGINEERING TEAM. IT WAS FOUND THAT SOME PINS WERE BROKEN AWAY FROM THE TOP BOARD AND THERE WAS EVIDENCE OF CORROSION ON A CONNECTOR DUE TO FLUID INGRESS. ALL BOARDS WERE REPLACED DUE TO SYSTEM UPGRADES THAT ARE DESIGNED TO PREVENT FLUID INGRESS. THE ROOT CAUSE OF THE REPORTED INTERMITTENCY IS LIKELY THE RESULT OF ANTICIPATED WEAR/USE/MAINTENANCE CONDITION OF THE DEVICE. THE DEVICE WAS REPAIRED, TESTED TO SPECIFICATIONS, AND RETURNED TO THE CUSTOMER. METHODS: ACTUAL DEVICE EVALUATED; MECHANICAL EVALUATION; VISUAL INSPECTION RESULTS: WEAR PROBLEM. CONCLUSION: DEVICE REPAIRED AND RETURNED

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PREAMPLIFIER WAS RETURNED TO SERVICE AND REPAIR WITH A REPORT OF WORKING INTERMITTENTLY. THE CUSTOMER REPORTED THEY FOUND PINS INSIDE THAT WERE CORRODED AND TRIED CLEANING THEM. THE UNIT ONLY WORKS INTERMITTENTLY NOW AND SOMETIMES NOT AT ALL. THE USER SWITCHED OUT THE DEVICE FOR ANOTHER PREAMPLIFIER FOR THE CASE. THERE WAS NO PATIENT IMPACT OR REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333943 AXON DIGITAL PREAMPLIFIER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. 945DAQ916 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1