BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 2811803 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16402
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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). THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED CUT. VISUAL ANALYSIS NOTED THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD WAS DIFFICULT TO POSITION AND COULD NOT REACH THE TARGET POSITION. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4574

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other