BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790851 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14782
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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) THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS OBSERVED ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ALL THREE LEADS DISLODGED. THE PATIENT FELT THE DEVICE "FLIP" IN THEIR CHEST AND EXPERIENCED DIAPHRAGMATIC STIMULATION AFTERWARDS. THE PATIENT PROCEEDED TO THE ER WHERE A CHEST X-RAY SHOWED GROSS LEAD DISLODGEMENTS OF ALL THREE LEADS. THE PHYSICIAN FELT THAT THE CAN FLIPPED OVER IN THE PATIENT'S POCKET AND RESULTED IN THE LEADS DISLODGING. THE LEFT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR AND RIGHT ATRIAL LEADS WERE REPOSITIONED AND REMAIN IN USE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R