BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1792344 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07080
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    May 4, 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
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THERE WAS ATRIAL LEAD WARNING. THE BIPOLAR IMPEDANCE WAS LOWER THAN UNIPOLAR IMPEDANCE ON THE ATRIAL LEAD. THE LEAD WAS REPLACED. 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 4076 IMPLANTABLE PACING LEAD| E2DR01 IMPLANTABLE PULSE GENERATOR| 4024 IMPLANTABLE PACING LEAD