BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3862110 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07048
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: PRODUCT ID 5076-52 LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DISCOVERED THAT IN TESTING THE VENTRICULAR LEAD IT WAS ACTUALLY CAPTURING THE ATRIUM. FLUOROSCOPY WAS PERFORMED AND THE LEAD WAS NOTED TO BE PULLED BACK AND WAS NOT IN THE VENTRICLE. PHYSICIAN ATTEMPTED TO IMPLANT NEW RIGHT VENTRICULAR (RV) LEAD ON LEFT SIDE BUT COULD NOT GET ACCESS AND HAD TO GO TO RIGHT SIDE TO GET ACCESS. THE LEAD WAS CAPPED AND ABANDONED. A NEW LEAD WAS IMPLANTED ON THE RIGHT SIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342430 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR Hospitalization| R E2DR01AA IPG