BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 9172870 · Received October 9, 2019

    Report

    Report Number
    2649622-2019-18460
    Event Type
    Injury
    Date Received
    October 9, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 9, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124867
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: W3DR01 IPG, IMPLANTED: (B)(6) 2019; A7700-29 VALVE, IMPLANTED: (B)(6) 1998. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE GENERATOR CHANGE THE INCISION SITE DID NOT HEAL, LEAVING THE IMPLANTABLE PULSE GENERATOR (IPG) EXPOSED. THE IPG SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966775 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58 00681490124867

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R 5076-52 LEAD