BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 8806310 · Received July 19, 2019

    Report

    Report Number
    2649622-2019-12617
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    June 19, 2019
    Report Date
    July 19, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490125048
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 5592-45 LEAD, IMPLANTED: (B)(6) 2005. 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'S IPG SYSTEM WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602166 CAPSURE SP NOVUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-52 00681490125048

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R W1DR01 IPG