BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 2964863 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02063
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 12, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: SDR203B IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT PROCEDURE, IT WAS NOTED THERE WAS A POSSIBLE INSULATION BREACH ON THE ATRIAL LEAD. THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67926 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4504M53

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Hospitalization| R 5024M IIMPLANTABLE PACING LEAD