BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811260 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16592
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVALUATION SUMMARY: (B)(4)THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. HOWEVER, IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING AND SUBSEQUENTLY RETRACTING THE LEAD THROUGH THE INTRODUCER. THE PHYSICIAN FELT THAT THE COIL WAS "HANGING UP." THE LEAD WAS THEN REMOVED AND REPLACED WITH A NEW LEAD. IT WAS NOTED THAT AFTER REMOVING THE LEAD THE PHYSICIAN NOTED SOME STRETCHING OF THE PROXIMAL COIL. 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 73 YR Other 5076 IMPLANTABLE PACING LEAD