BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND II

    MDR report key: 7090727 · Received December 7, 2017

    Report

    Report Number
    2647346-2017-00037
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    October 17, 2017
    Report Date
    December 6, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LWO
    PMA / PMN Number
    P850051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE COULD NOT BE INTERROGATED, HAD NO OUT, AND NO MAGNET RESPONSE. THE DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876698 LEGEND II PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE LWO MDT PUERTO RICO OPERATIONS CO, MED REL 8426

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR