BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991644 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08001
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. (B)(4). EVALUATION SUMMARY: ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, HOWEVER VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE; PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS REPLACED DUE TO INCREASING HIGH THRESHOLDS AND DECREASING LEAD IMPEDANCE. THE LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471117 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R ADDR01 IPG, 5076-52 LEAD