BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8663402 · Received June 3, 2019

    Report

    Report Number
    2649622-2019-09452
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    April 5, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124812
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DTBA1D1, CRT-D IMPLANTED (B)(6) 2014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION. THE PATIENT RECEIVED A NEW SYSTEM THE FOLLOWING MONTH. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455758 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00681490124812

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 694765 LEAD, 419588 LEAD