BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS LEAD

    MDR report key: 11272637 · Received February 3, 2021

    Report

    Report Number
    2649622-2021-02137
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 18, 2021
    Report Date
    February 3, 2021
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND WILL NOT BE REPLA CED. THE PACING LEADS WERE INACTIVATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169700 CAPSURE Z NOVUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R ATDRS1 IPG, 5076-52 LEAD