BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3990813 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08461
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 PRODUCT: 4524 LEAD, IMPLANTED: (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BACTEREMIA AND POSITIVE BLOOD CULTURES FOR VANCOMYCIN RESISTANT ENTEROCOCCUS. IT WAS FURTHER REPORTED THAT THE CAUSE OF THE BACTEREMIA WAS UNABLE TO BE DETERMINED, THEREFORE, THE PHYSICIAN RECOMMENDED THE EXPLANT OF PACEMAKER AND LEADS. THE DEVICE AND LEADS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469742 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R ADDR01 IPG