BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2810846 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16314
    Event Type
    Injury
    Date Received
    October 31, 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
    MO
    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 PATIENT RECEIVED AN INAPPROPRIATE THERAPY DUE TO DEVICE TREATING A SUPRAVENTRICULAR TACHYCARDIA AS A VENTRICULAR FIBRILLATION (VF). THE DEVICE REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT HAS A HISTORY OF CHRONICALLY LOW P WAVES ACCOMPANIED BY FAR FIELD R WAVE OVERSENSING. THE LEAD REMAINS IN USE. NO FURTHER 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4574

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening 6947 IMPLANTABLE TACHY LEAD