BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790030 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15295
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 25, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL THREE LEADS DISLODGED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMLUATION FROM THE ATRIAL LEAD. THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS WERE REPOSITIONED AND ARE STILL IN USE. THE LEFT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED PER PHYSICIAN'S JUDGMENT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R D314TRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB