BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2952727 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00679
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 22, 2011
    Report Date
    November 22, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    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 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 THERE WAS OVERSENSING ALONG WITH SOME UNDERSENSING AND INADEQUATE PACING ON THE VENTRICULAR LEAD. THE ATRIAL LEAD WAS ALSO FOUND TO BE OVERSENSING FAR-FIELD R WAVES. THE SENSING ISSUES LED TO MODE SWITCHES ALONG WITH OVER AND UNDERSENSING OF THE ATRIAL LEAD. BOTH THE ATRIAL AND VENTRICULAR LEADS WERE REPROGRAMMED AND REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE SYSTEMS LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56881 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4068 IMPLANTABLE PACING LEAD