BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 4160042 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12068
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF SYNCOPAL EPISODES, AND THE LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCES AND HIGH THRESHOLDS WITH INTERMITTENT CAPTURE. FURTHER INVESTIGATION REVEALED THAT THE LEAD WAS NOT FULLY SEATED WITHIN THE DEVICE HEADER. THE LEAD WAS RECONNECTED, AND FURTHER MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE LEAD AND DEVICE 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
    637908 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| L| R SESR01 IPG