BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8685965 · Received June 11, 2019

    Report

    Report Number
    2649622-2019-09930
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 11, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169633766
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED DUE TO 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
    482726 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58 00643169633766

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R W1DR01 IPG, 5076-52 LEAD