BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE 8225825 3PK INCREMT STD PRASS TIP

    MDR report key: 3191641 · Received June 26, 2013

    Report

    Report Number
    1045254-2013-00435
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K934426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, NO DEVICES WERE RECEIVED FOR EVALUATION DUE TO THE FACILITY DISPOSING OF THEM. HOWEVER, 1 UN-OPENED DEVICE OF THE SAME LOT NUMBER WAS RETURNED FOR EVALUATION ON (B)(4) 2013. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION OF THE MALFUNCTIONING DEVICES COULD BE PERFORMED. (B)(4).

    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 2 INCREMENTING STANDARD PRASS TIP PROBES WOULD NOT WORK WHEN HOOKED UP TO THE NIM MONITOR. THE FACILITY DISPOSED OF THE 2 MALFUNCTIONING PROBES, HOWEVER 1 UN-OPENED PROBE WITH THE SAME LOT NUMBER WAS RETURNED FOR EVALUATION. THERE IS NO KNOWN IMPACT OR INJURY TO THE PATIENT AND NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290376 PROBE 8225825 3PK INCREMT STD PRASS TIP STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8225825 0206840121

    Patients

    Seq Age Sex Outcome Treatment
    1