BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3051861 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04771
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 1, 2008
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO, VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT VENTRICULAR LEAD DISLODGEMENT OCCURRED WITHIN APPROXIMATELY ONE MONTH AFTER THE IMPLANT OF THE LEAD. THE LEAD WAS REPOSITIONED AND REMAINS IN SERVICE. THE PATIENT WAS REPORTED TO HAVE BEEN ENROLLED IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152175 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO, VILLALBA 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R