BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3151534 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05500
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS OVERSENSING AND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT IS PACING DEPENDENT SO A TEMPORARY PACING WIRE WAS INSERTED PRIOR THE NEW LEAD BEING IMPLANTED. IT WAS NOTED THAT THE PATIENT WAS ENROLLED IN THE SYSTEM LONGEVITY STUDY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) IMPLANTABLE PACING LEAD WAS FRACTURED AND THERE WAS NOISE ON THE RIGHT ATRIUM (RA) IMPLANTABLE PACING LEAD. BOTH LEADS WERE 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
    252738 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R