BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4831600 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05466
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 20, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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 REPORTED THAT DUE TO THE PATIENTS ANATOMY AND CONDITION OF THORACIC OUTLET SYNDROME (TOS) THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE REMOVED. THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RE-IMPLANTED ON THE RIGHT SIDE UTILIZING NEW RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS AND USING THE ORIGINAL IPG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375626 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 5076-52, LEAD / A2DR01, IPG