BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811645 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17125
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    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 PRODUCT WAS NOT RETURNED TO THE MANUFACTURER, BUT PERFORMANCE DATA WAS RECEIVED AND ANALYZED. THE SAVE TO DISK NOTED LEAD IMPEDANCE WAS OUT OF RANGE LOW. TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE (B)(6) 2012 AND (B)(6) 2012. WEEKLY PACE LEAD IMPEDANCE TREND, DECREASE FOR MIN VENTRICULAR PACE BI EQUAL TO 532 TO 171 OHMS MINIMUM BETWEEN (B)(6) 2012 AND (B)(6) 2012. THE SAVE TO DISK NOTED OVERSENSING. NINE VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN OR EQUAL TO 210 MS BETWEEN (B)(6) 2012 AND (B)(6) 2012.

    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 THE RIGHT VENTRICULAR LEAD TRIGGERED AN ALERT FOR LOW IMPEDANCE. EPISODES WITH OVERSENSING WERE NOTED WHEN RUNNING CAPTURE MANAGEMENT. THE LEAD 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 LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB