BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1925452 · Received December 14, 2010

    Report

    Report Number
    2182208-2010-00997
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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 THE DEVICE WAS UNDERSENSING P-WAVES. THE DEVICE WAS PROGRAMMED TO A SENSITIVITY OF 0.18MV AND APPROPRIATE SENSING RETURNED. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC, INC. IPG/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention