BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860258 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05519
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    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. PRODUCTS: ADDRL, IPG, IMPLANTED: 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND SYNCOPE. THE PHYSICIAN FOUND OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD AND ADJUSTED THE LEAD PROGRAMMING. ONE WEEK LATER, THE PATIENT EXPERIENCED LIGHT HEADEDNESS, SYNCOPE, AND CHEST PAIN. INTERROGATION FOUND INTERMITTENT FAILURE TO CAPTURE ON THE RV LEAD AS WELL AS HIGH THRESHOLDS. THE PHYSICIAN COULD NOT TELL IF THE LOSS OF CAPTURE WAS DUE TO THE RV LEAD OR THE DEVICE SO BOTH WERE 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
    343249 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| L| R 5076-45, LEAD