BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2791023 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14794
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 TO THE EMERGENCY ROOM FOR POCKET STIMULATION. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS PROGRAMMED UNIPOLAR AND THE UNIPOLAR IMPEDANCE WAS AT 346 OHMS. BIPOLAR IMPEDANCE WAS LESS THAN 100 OHMS AND THERE WAS HIGH OUTPUT. THE CALLER WAS UNSURE IF THERE WAS MYOPOTENTIAL OR EXTERNAL NOISE. THE RV LEAD OUTPUT WAS ADJUSTED TO A LOWER OUTPUT AND THE LEAD REMAINS IN USE. 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. 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R SESR01 PACEMAKER