BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2790627 · Received October 15, 2012

    Report

    Report Number
    3008973940-2012-00043
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 1, 2012
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD PERFORATED THE RIGHT VENTRICLE.IT WAS NOTED THAT THE LEAD HAD HIGH THRESHOLDS AND NO CAPTURE AT MAXIMUM PACING OUTPUT. THE LEAD WAS REPOSITIONED AND ACCEPTABLE THRESHOLD, SENSING AND IMPEDANCES WERE GAINED. IT WAS NOTED TAHT THE PATIENT HAS LEFT SIDED CHEST DISCOMFORT DUE TO THE LEAD MOVING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 SINGAPORE OPERATIONS 4574

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R