BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1992312 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02760
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND, FULL LEAD WAS ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEAD, AFTER BEING POSITIONED IN THE RIGHT VENTRICLE, THE LEAD DISLODGED, AND WAS REPOSITIONED MULTIPLE TIMES BEFORE THE PHYSICIAN DECIDED THAT A LONGER LEAD WOULD BE NEEDED FOR THE RIGHT VENTRICLE. THE LEAD WAS THEN REMOVED FROM THE RIGHT VENTRICLE, AND IMPLANTED IN THE ATRIUM. THE LEAD REMAINS IN USE. A DIFFERENT LEAD, THAT WAS ORIGINALLY INTENDED TO BE USED IN THE ATRIUM, WAS OPENED BUT NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R