BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1991855 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00160
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 9, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 LEAD PRESENTED WITH LOW IMPEDANCE IN BIPOLAR SENSING WITH A HIGH PACING THRESHOLD. A NEW RIGHT VENTRICULAR LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT WAS UNSUCCESSFUL DUE TO THE PATIENT'S ANATOMY. THE CHRONIC RIGHT VENTRICULAR LEAD WAS REUSED. 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 PACING LEAD DTB MEDTRONIC, INC. LEAD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R 4524 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR