BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2791669 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15150
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 EXHIBITED STEADILY INCREASING IMPEDANCES TO HIGH LEVELS, AND WOULD NO LONGER CAPTURE AT THE HIGHEST OUTPUT. THE LEAD WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED STEADILY INCREASING IMPEDANCES TO HIGH LEVELS, AND WOULD NO LONGER CAPTURE AT THE HIGHEST OUTPUT. IT WAS FURTHER REPORTED THAT THE LEAD EXHIBITED HIGH THRESHOLDS AND AN APPARENT FRACTURE. THE LEAD WAS PROGRAMMED OFF, AND WILL BE 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 SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 4574

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 4074 IMPLANTABLE PACING LEAD| SDR203 IMPLANTABLE PULSE GENERATOR