BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1863076 · Received October 9, 2010

    Report

    Report Number
    2182208-2010-00758
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 19, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 VENTRICULAR LEAD HAD LOW IMPEDANCE. A NEW LEAD HAD HIGH THRESHOLD AND COULD NOT BE IMPLANTED SUCCESSFULLY. THE VENTRICULAR LEAD WAS REPOSITIONED SUCCESSFULLY AND 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 PACING LEAD DTB MEDTRONIC, INC. LEAD/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention 4068 IMPLANTABLE PACING LEAD| 7960 IMPLANTABLE PULSE GENERATOR