BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3160338 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08026
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    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

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NOANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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 WAS DIAGNOSED WITH (B)(6) OF UNKNOWN SOURCE APPROXIMATELY TWO YEARS AFTER IMPLANT. THE PATIENT WAS TREATED WITH ANTIBIOTIC TREATMENT AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED. NO PATIENT FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259808 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| R D224DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR