BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953227 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00976
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: 6949 IMPLANTABLE TACHY LEAD (B)(6) 2005, BETA BLOCKER, ACE INHIBITOR, WARFARIN, DIURETIC, STATIN, ANTIBIOTIC. (B)(4). NO EVAL EXPLANATION: THE LEAD WAS NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RECURRENT (B)(6) BACTEREMIA. TRANSESOPHAGEAL ECHOCARDIOGRAPHY DONE SHOWED ECHODENSITY ON THE RIGHT VENTRICULAR LEAD AS IT TRANSVERSES THE RIGHT ATRIAL LEAD AND 2+ MR WITH A POST LEAFLET VALVE ECHODENSITY. THE SYSTEM 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
    55756 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR