BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 1072304 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00332
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    October 25, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INTERMITTENT CAPTURE AND NO OUTPUT. FURTHER, THE LEAD WAS REPORTED TO BE "BROKEN/FAULTY" AND WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: COMPONENT/SUBASSEMBLY FAILURE. DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT; CAPTURE, INTERMITTENT, OUTPUT, NONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INTERMITTENT CAPTURE AND NO OUTPUT. FURTHER, THE LEAD WAS REPORTED TO BE "BROKEN/FAULTY" AND WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD