BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161025 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11674
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC PACING DUE TO DISLODGEMENT OF THE RIGHT ATRIAL (RA) LEAD THAT OCCURRED DURING AN EARLIER FALL. THE LEAD WAS EXPLANTED 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
    642081 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R ADDR01 IPG, 5076-65 LEAD