BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2781681 · Received October 10, 2012

    Report

    Report Number
    2649622-2012-12888
    Event Type
    Injury
    Date Received
    October 10, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 AFTER A CARDIOVERSION, THE ATRIAL LEAD IMPEDANCE WAS HIGH. UPON REINTERROGATION, THE LEAD TRENDS SHOWED VARIABLE LEAD IMPEDANCES. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD UNDEFINED IMPEDANCE AND THE RIGHT VENTRICULAR LEAD HAD A VISIBLE CRACK IN THE INSULATION NEAR THE ANCHORING SLEEVE. BOTH LEADS WERE CAPPED AND 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 NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R