BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2810158 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15643
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    February 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THE ANALYSIS OF THE DATA REVEALED THAT ATRIAL LEAD BIPOLAR IMPEDANCE AVERAGES 495OHMS FOR 29 WEEKS PRECEDING A JUMP TO >3000 OHMS FOR THE 4 WEEKS AFTER THE WEEK ENDING (B)(4) 2012. DAILY IMPEDANCE VARIES BETWEEN 500 AND >3000 OHMS FOR THE PREVIOUS 15 DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCE AND AN APPARENT FRACTURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| O| R A4DR01 IMPLANTABLE PULSE GENERATOR