BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 1072434 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00309
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    September 5, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: IT WAS REPORTED THAT THE DEVICE HAD NO OUTPUT AND NO PACING. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, OUTPUT, NONE, PACE, FAILURE TO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD NO OUTPUT AND NO PACING. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 5092 IMPLANTABLE PACING LEAD