BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812548 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16934
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 28, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING NOTED THAT NO ANOMALIES WERE FOUND. THE LEAD CABLE/COIL CONDUCTOR WAS NOT OBSTRUCTED AT THE LV1/DISTAL WITH BLOOD. THE DISTAL END/ELECTRODES WERE COVERED AT THE LV1/DISTAL WITH BLOOD. THERE WAS INSULATION BREACH (EXTRINSIC) OVERLAY TUBING CUT. THERE WAS INSULATION BREACH (EXTRINSIC) OUTER INSULATION CUT. VISUAL ANALYSIS NOTED THE LEAD WAS DAMAGED AT IMPLANT.

    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 PROCEDURE THERE WERE SEVERAL ATTEMPTS TO POSITION THE RIGHT VENTRICULAR LEAD THAT RESULTED IN POOR SENSING AND THRESHOLD MEASUREMENTS. THE ATTEMPTED LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other