BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812787 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15958
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 7, 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED HIGH RV LEAD IMPEDANCE.

    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 ONE WEEK POST IMPLANT, THE PATIENT ALERT WAS TRIGGERED DUE TO HIGH PACING IMPEDANCE. HIGH THRESHOLDS WERE NOTED AS WELL. UPON LEAD REVISION, IT WAS NOTED THAT THERE WAS A CONNECTOR ISSUE. THE LEAD WAS REVISED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK POST IMPLANT, THE PATIENT ALERT WAS TRIGGERED DUE TO HIGH PACING IMPEDANCE. HIGH THRESHOLDS WERE NOTED AS WELL. UPON LEAD REVISION, IT WAS NOTED THAT THERE WAS A CONNECTOR ISSUE. THE LEAD WAS REVISED 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 66 YR Hospitalization| R 5568 IMPLANTABLE PACING LEAD| D314DRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB