BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812112 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16656
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    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.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) - THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. PRIMARY ANALYSIS FINDING NOTED ISSUE WITH LEAD FIXATION OF HELIX. THE LEAD CONDUCT FRACTURED. PERFORMANCE DATA WAS COLLECTED AND ANALYZED. THE RV LEAD INTEGRITY ALERT TRIGGERED. ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. THE RV PACING IMPEDANCE WAS OUT OF RANGE HIGH. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE (B)(6) 2012 . WEEKLY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASED FOR MAX VENTRICULAR PACE BI-IMPEDANCE = 475 TO 4047 OHMS PEAK BETWEEN (B)(6) 2012. THE RV SENSING FUNCTION WAS OVERSENSING. FIFTEEN VENTRICULAR NST<(><<)>= 210 MS BETWEEN (B)(6) 2012. VF<(><<)>= 210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2012. THE SENSING FUNCTION WAS OVERSENSING NON-PHYSIOLOGIC/SHORT INTERVAL COUNTS (SIC). VENTRICULAR SIC= 85349 COUNTS N 22.38 DAYS, BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS AND WAS IN THE EMERGENCY ROOM BEING MONITORED. THE RIGHT VENTRICULAR LEAD HAD NOISE AND OVERSENSING. THE DETECTIONS WERE TURNED OFF AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT DUE TO A FRACTURE. THE LEAD WAS EXPLANTED AND WAS REPLACED.

    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 67 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB