BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3276854 · Received August 9, 2013

    Report

    Report Number
    2182208-2013-02107
    Event Type
    Injury
    Date Received
    August 9, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: PACEMAKER LEAD INFECTION AND RELATED BACTERAEMIA CAUSED BY NORMAL AND SMALL COLONY VARIANT PHENOTYPES OF BACILLUS LICHENIFORMIS. J. MED. MICROBIOL. JUNE 1 2013;62(PART6):940-944. CONCOMITANT PRODUCTS: PRODUCT ID KDR401 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).  (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. THE PATIENT DEVELOPED SEPSIS AND BACILLUS LICHENIFORMIS. THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY AND THE LEAD REMAINED IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380250 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R