BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2813000 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16716
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 16, 2011
    Report Date
    February 27, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061/S10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE UNIPOLAR VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED. IT WAS NOTED THAT THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY. 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 SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4023

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R