BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 4163458 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12318
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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: A 5054-58 LEAD IMPLANTED: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED AND THERE WAS VEGETATION NOTED ON ONE AND POSSIBLY BOTH LEADS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640406 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R VEDR01 IPG