BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVA DR

    MDR report key: 2790633 · Received October 15, 2012

    Report

    Report Number
    2647346-2012-01700
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 8, 2002
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S43
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AFTER THE USE BEFORE DATE AND HAS NOW REACHED ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AFTER THE USE BEFORE DATE AND HAS NOW REACHED ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE 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 PREVA DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 7088

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R 5024M X2 IMPLANTABLE PACING LEAD