BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1864653 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10699
    Event Type
    Injury
    Date Received
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 AN X-RAY SHOWED AN INSULATION BREAK (APPARENT CONDUCTOR FRACTURE) AND HIGH THRESHOLD. IT WAS ALSO REPORTED THAT THE LEAD HAD LOW IMPEDANCE IN UNIPOLAR MODE AND INTERMITTENT MUSCLE STIMULATION. THE LEAD WAS CAPPED AND REPLACED. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SDR303 IMPLANTABLE PULSE GENERATOR| 5592 IMPLANTABLE PACING LEAD