BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    MDR report key: 3025362 · Received March 28, 2013

    Report

    Report Number
    1045254-2013-00306
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). EVALUATION SUMMARY: THE CUSTOMER STATED THAT THE INTERFACE WAS WORKING INTERMITTENTLY. DURING REPAIR, THE CUSTOMER'S COMPLAINT WAS UNABLE TO BE DUPLICATED, THE UNIT WAS FOUND TO MEET SPECIFICATION; HOWEVER, COMMUNICATION WITH THE CUSTOMER REVEALED THAT THE CUSTOMER HAD IDENTIFIED A LOOSE CONNECTION IN CHANNEL 1 AND HAD RE-SOLDERED THE CONNECTION. BASED ON THE REPAIR OUTCOME AND THE REPAIR HISTORY, THE 'MOST LIKELY' CAUSE OF THE EVENT IS ANTICIPATED USE CHARACTERISTICS LEADING TO THE MALFUNCTIONING INTERNAL CONNECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS WORKING INTERMITTENTLY. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128531 INTERFACE 8252800 RESPONSE 2.0 INCREMENT STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252800 60521400

    Patients

    Seq Age Sex Outcome Treatment
    1