BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1792309 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07068
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 DURING DEVICE CHANGEOUT THE BIPOLAR IMPEDANCE WAS LOWER THAN UNIPOLAR IMPEDANCE ON THE ATRIAL LEAD, AND INNER INSULATION BREAKDOWN WAS SUSPECTED. THE LEAD WAS PROGRAMMED TO UNIPOLAR MODE, AND IS 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 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 5068 IMPLANTABLE PACING LEAD