BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993617 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09214
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: D274DRG DEVICE, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL (RA) LEAD PACING THRESHOLDS WERE READING HIGH. THE LEAD WAS EXAMINED UNDER FLUOROSCOPY WHICH REVEALED THE LEAD WAS IN A DIFFERENT POSITION FROM THE ORIGINAL IMPLANT LOCATION. THE LEAD WAS CAPPED AND REPLACED ALONG WITH THE REPLACEMENT OF THE ASSOCIATED DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467702 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R 694765 LEAD