BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2811128 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16342
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE RIGHT ATRIAL AND THE RIGHT VENTRICULAR LEADS BOTH HAD "SLIGHTLY HIGH THRESHOLDS." IT WAS FURTHER REPORTED THAT THE ATRIAL AND RIGHT VENTRICULAR LEADS CONTINUED TO EXHIBIT HIGH THRESHOLDS. THE LEADS WERE CAPPED AND REPLACED. ADDITIONALLY, THE DEVICE EXHIBITED UNEXPECTED LONGEVITY, AND WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THISEVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL AND THE RIGHT VENTRICULAR LEADS BOTH HAD "SLIGHTLY HIGH THRESHOLDS." THE LEADS REMAIN 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 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| R VEDR01 IMPLANTABLE PULSE GENERATOR