BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3860067 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05596
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 15, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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: ADDR01, IPG, IMPLANTED (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER AN EPISODE OF SYNCOPE AND SUBSEQUENT FALL AT HOME. A SPIKE HAD BEEN SEEN IN RIGHT VENTRICULAR (RV) THRESHOLDS AND THEY HAD BECOME UNSTABLE, ONLY CAPTURING THE VENTRICLE INTERMITTENTLY. OUTPUT WAS INCREASED AND SENSITIVITY ADJUSTED UNTIL THE LEAD COULD BE REVISED. SOME ARTIFACT WAS ALSO OBSERVED NEAR THE FIRST RIB AND CLAVICLE. A CLAVICLE CRUSH OR FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340421 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 5554 LEAD