BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 2811062 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16578
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S15
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PATIENT PRESENTED WITH A VENTRICULAR LEAD WARNING. THE IMPEDANCE HAD INCREASED TO HIGH MEASUREMENTS. THE LEAD REMAINS IN USE BUT A CONSULT WILL OCCUR ON FURTHER INTERVENTION. IT WAS NOTED THAT THE PATIENT EXPERIENCED PALPITATIONS, BUT WERE MOST LIKELY DUE TO THE PATIENT'S ATRIAL FIBRILLATION. NO OTHER 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. 5024M

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 4524 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR