BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3991509 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08074
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    September 28, 2007
    Report Date
    May 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. PRODUCT: 5076 LEAD IMPLANTED 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT ONE OF THEIR LEADS WAS PLACED INCORRECTLY BY THE PHYSICIAN AND BECAUSE, IT WAS ¿ROUTED WRONG¿ THE PATIENT HAD TO GO THROUGH A PROCEDURE AGAIN. THE PATIENT COULD NOT STAND UP AND HAD A BURNING SENSATION IN THE CHEST. THE PATIENT ALSO REPORTED THAT WHILE IN THE HOSPITAL THE NURSE ¿CAME FLYING THROUGH THE PATIENT¿S ROOM AND RIPPED ALL OF THE TUBES OUT OF THE PATIENT¿. FOLLOW-UP INFORMATION FROM THE CLINIC INDICATES THE RIGHT VENTRICULAR (RV) LEAD DISLODGED TWO DAYS AFTER A DEVICE REPLACEMENT. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469354 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R VEDR01 IPG