BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8905225 · Received August 19, 2019

    Report

    Report Number
    2649622-2019-14529
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 19, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490124867
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4058M58 LEAD, 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 FURTHER REPORTED THAT THE RV LEAD EXHIBITED HIGH IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD MEASUREMENTS WERE OBSERVED TO BE OUTSIDE OF THERAPEUTIC PARAMETERS. IT WAS ALSO REPORTED THAT A SUSPECTED FRACTURE WAS OBSERVED. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701905 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58 00681490124867

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R VEDR01 IPG