BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991687 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07985
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 PRODUCT: 5076-52 LEAD, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH UNSTABLE THRESHOLDS AND HIGH IMPEDANCE. THE ATRIAL LEAD WAS REPROGRAMMED TO SENSING ONLY AND REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INTERMITTENT LOC (LOSS OF CAPTURE), HIGH THRESHOLDS, AND HIGH IMPEDANCE. POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE RV 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
    468440 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR Hospitalization| R SEDR01 IPG