BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955195 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00842
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 21, 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

    (B)(4): 6949 IMPLANTABLE TACHY LEAD 2005-(B)(6), 4194 IMPLANTABLE PACING LEAD 2010-(B)(6), DOFETILIDE, DIGOXIN, HEPARIN, DIURETIC, STATIN, BETA BLOCKER, ANGIOTENSIN RECEPTOR BLOCKER. (B)(4): NO EVAL EXPLAINATION: LEAD NOT RETURNED TO 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 A POCKET INFECTION AND ENDOCARDITIS. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED. NO PATIENT CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58138 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR