BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2965113 · Received February 15, 2013

    Report

    Report Number
    2182208-2013-00377
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 4, 2007
    Report Date
    December 18, 2012
    Manufacturer
    RICE CREEK MFG
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE OF 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).

    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 FOUR DAYS POST IMPLANT, THE ATRIAL LEAD WAS NOTED TO BE UNDERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT 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
    67566 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R