BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY II DR

    MDR report key: 2953321 · Received February 9, 2013

    Report

    Report Number
    2647346-2013-00010
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POWER ON RESET (POR). THE POR WAS CLEARED DURING INTERROGATION AND THE DEVICE REMAINS IN USE. IT WAS ALSO NOTED THAT THE PATIENT HAS EPISODES OF BREATHLESSNESS AND IS SCHEDULED FOR AN ELECTROPHYSIOLOGY (EP) STUDY TO DETERMINE THE CAUSE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56996 LEGACY II DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MDT PUERTO RICO OPERATIONS CO, MED REL 828

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) IMPLANTABLE PACING LEAD