BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY II SR

    MDR report key: 2201897 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-01010
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S43
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED AND HAD NO MAGNET RESPONSE. THE DEVICE WAS AT END OF LIFE (EOL) AND WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGACY II SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R COMPETITOR IMPLANTABLE PACING LEAD