BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812979 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15975
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM TWO DAYS POST IMPLANT. IT WAS NOTED THAT THE PATIENT WENT HOME POST IMPLANT AND TRIPPED OVER THE PATIENT'S DOG AND FELL DOWN. IT WAS ALSO REPORTED THAT THE LEAD HAD INTERMITTENT CAPTURE AND WAS DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R SR53 COMPETITOR IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR| SR45 COMPETITOR IMPLANTABLE PACING LEAD