BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3861454 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07278
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. CONCOMITANT MEDICAL PRODUCTS: 4524-53, LEAD, IMPLANTED: (B)(6) 1996. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBABLE PERFORATION OF THE RIGHT VENTRICLE ALONG WITH DIAPHRAGMATIC STIMULATION. LOW IMPEDANCE WAS ALSO NOTED WITH POLARITY SWITCH. THE LEAD WAS LEFT IN USE AT A LOWER VOLTAGE PROGRAMMED TO VVI 30, AS THE PATIENT IS VERY ACTIVE AND PACEMAKER DEPENDENT. THE LEAD WILL BE TURNED OFF WHEN THE REPLACEMENT LEAD, NEWLY IMPLANTED ON THE RIGHT SIDE, IS FULLY MATURED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342586 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| L| R ADDR01 IPG