BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8741118 · Received June 27, 2019

    Report

    Report Number
    2649622-2019-11099
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    June 7, 2019
    Report Date
    June 27, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124799
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 6945-65 LEAD, IMPLANTED: (B)(6) 1998; M7700-31 MECHANICAL VALVE, IMPLANTED: (B)(6) 1994. 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 CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. CULTURES WERE TAKEN, AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE CULTURES TESTED POSITIVE FOR STAPH CAPITUS. A NEW ICD SYSTEM WAS IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532647 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45 00681490124799

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R DDMB1D1 ICD