BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1991598 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02445
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): TIP ELECTRODE PULLED OUT FROM THE RING, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE INNER INSULATION WAS TORN AND THE LEAD APPEARED DAMAGE AT IMPLANT; PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE RIGHT VENTRICULAR LEAD GOT STUCK AT THE JUNCTION OF THE RIGHT ATRIUM AND SVC OR SOMEWHERE IN THE RIGHT ATRIUM. WHILE ATTEMPTING TO REPOSITION THE LEAD, THE INSULATION SEPARATED AND CAME OFF LIKE A SLEEVE. THE LEAD CONDUCTOR WAS LEFT INSIDE THE RIGHT ATRIUM WITH THE PROXIMAL END ANCHORED TO THE POCKET. A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| O