BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 2952746 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00688
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 14, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OPEN HEART SURGERY, THE THRESHOLD INCREASED ON THE RIGHT VENTRICULAR LEAD AND THE THRESHOLD ON THE RIGHT ATRIAL LEAD WAS HIGH. THE RIGHT VENTRICULAR LEAD COULD NOT BE REMOVED, SO IT WAS SUBSEQUENTLY CAPPED AND REPLACED. THE RIGHT ATRIAL LEAD WAS EXPLANTED 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
    57007 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR