BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4162867 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12585
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ONE DAY AFTER THE IMPLANT PROCEDURE, BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR (RV) LEADS WERE DISLODGED, AS CONFIRMED ON X-RAY. POOR SENSING AND ELEVATED THRESHOLDS WERE ALSO NOTED. THE LEADS WERE REPOSITIONED. ON THE NEXT DAY'S DEVICE INTERROGATION, THE RV LEAD AGAIN SHOWED ELEVATED THRESHOLD AND INTERMITTENT NON-CAPTURED. THE RV LEAD WAS REPOSITIONED A SECOND TIME AND BOTH LEADS REMAIN IN USE. THE PHYSICIAN NOTED THE PATIENT WAS NON-COMPLIANT WITH ORDERS AND GETTING OUT OF BED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640047 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5592-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R 5092-52 LEAD, ADDR01 IPG