BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3062211 · Received April 16, 2013

    Report

    Report Number
    2182208-2013-01091
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    January 20, 2010
    Report Date
    February 8, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS NOTED THIS PATIENT IS ENROLLED IN THE MINIMIZE RIGHT VENTRICULAR PACING TO PREVENT ATRIAL FIBRILLATION AND HEART FAILURE (MINERVA) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162841 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R