BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPULSE

    MDR report key: 2050748 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01483
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THERE ARE NO NUMBERS FOR MEASUREMENTS ON VENTRICULAR CAPTURE MANAGEMENT (VCM). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS AND NOISE. BOTH THE LEAD AND THE DEVICE ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E2DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other (B)(4) IMPLANTABLE PACING LEAD