BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791196 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14810
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 DURING THE IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD THERE WAS OVERSENSING NOTED AND THE LEAD WAS RESET INTO THE HEADER. IT WAS ALSO REPORTED THAT POST OP DAY ONE NOISE WAS NOTED. AN X-RAY WAS OBTAINED AND WAS REPORTED AS NORMAL. THE RV LEAD WAS REPROGRAMMED 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 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD NVY MEDTRONIC PUERTO RICO, INC. 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| D314DRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB