BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813056 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16494
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 18, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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 WAS SEEN FOR A WOUND CHECK. THERE WAS NO CAPTURE ON THE ATRIAL LEAD AT MAXIMUM OUTPUT. AN X-RAY REVEALED THAT THE LEAD HAD DISLODGED. THE PATIENT DID COMMENT THAT "SOMETHING FELT STRANGE FOR ABOUT A DAY AFTER THE CHANGE OUT". THE DEVICE WAS TEMPORARILY PROGRAMMED TO VVI 40. THE PATIENT WAS SUBSEQUENTLY SEEN IN THE EMERGENCY ROOM THE FOLLOWING WEEKEND FOR SYMPTOMS ASSOCIATED WITH THE VVI PACING. THE LEAD IS STILL IN USE AND WILL BE EXPLANTED AND REPLACED. NO FURTHER 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. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R ADDRS1 IMPLANTABLE PACEMAKER| 4074 IMPLANTABLE PACING LEAD