BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3152422 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06814
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: 5568-53 IMPLANTABLE PACING LEAD, (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL DUE TO DISCOMFORT. OVERSENSING AND PACING FAILURE WERE CONFIRMED DURING A DEVICE CHECK, ALONG WITH NOISE, INCREASED THRESHOLD, AND HIGH IMPEDANCE. A TEMPORARY PACING LEAD WAS IMPLANTED. THE NEXT DAY DURING THE REPLACEMENT PROCEDURE, LEAD FRACTURE WAS SUSPECTED BASED ON ANALYZER MEASUREMENTS, AND THERE WAS LOW IMPEDANCE WHEN THE PATIENT BREATHED DEEPLY. THE RV (RIGHT VENTRICULAR) LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252685 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R KDR703 IMPLANTABLE PULSE GENERATOR