BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    MDR report key: 8621175 · Received May 17, 2019

    Report

    Report Number
    2649622-2019-08457
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 27, 2019
    Report Date
    October 2, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169633759
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE ANALYSIS INDICATED THAT THE DISTAL CONDUCTOR OF THE LEAD WAS EX TRINSICALLY OVER-ROTATED. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    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 ADDITIONALLY REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED ONE DAY POST-IMPLANT AND EXHIBITED HIGH CAPTURE OUTPUT. A REVISION WAS PERFORMED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413531 CAPSUREFIX NOVUS LEAD MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00643169633759

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R DTMA1QQ ICD, 5076-52 LEAD, 439888 LEAD