BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 4163191 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12422
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Removal / Correction Number
    N-029/030-4
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THIS DEVICE WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF EITHER THE PRODUCT OR PERFORMANCE DATA, OR COMPLETION OF ANALYSIS, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE HOSPITAL WITH SYNCOPE. THE DEVICE COULD NOT BE INTERROGATED AND WAS UNRESPONSIVE TO MAGNET APPLICATION. THE DEVICE IS SUSPECT TO BE AT END OF LIFE (EOL). THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO SENSE ANY R-WAVES EVEN THOUGH THE ELECTROCARDIOGRAM MONITOR SHOWED THAT THE PATIENT HAD AN UNDERLYING INTRINSIC RHYTHM. THE RV LEAD WAS FOUND TO HAVE LOW PACING IMPEDANCE. THE LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644326 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 400458

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R KSR703 IPG