BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955277 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00812
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MEDICAL PRODUCTS: 6949 IMPLANTABLE TACHY LEAD: (B)(6) 2006. 4193 IMPLANTABLE PACING: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE PATIENT WAS GIVEN ANTIBIOTIC TREATMENT FOR ENDOCARDITIS AND SEPSIS. THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58662 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| L| R D33TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR