BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2812227 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15918
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 THE DISTAL CONDUCTOR HAD FRACTURED. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE WAS NOTED AS THREE PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED BETWEEN (B)(6) 2012. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MIN AND MAX RV PACE = 480 TO INF(UN-FILTERED DATA) OHMS PEAK BETWEEN (B)(6) 2012. OVERSENSING WAS ALSO NOTED AS ELEVEN VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES <210 MS OCCURRED BETWEEN (B)(6) 2012. EIGHT VENTRICULAR FIBRILLATION EPISODES <=200 MS AVERAGE V-CYCLE OCCURRED BETWEEN (B)(6) 2012. INTERFERENCE/NOISE WAS NOTED AS VENTRICULAR SHORT INTERVAL COUNT WAS 305.8 COUNTS AVG/DAY, IN 5.13 DAYS, BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED ONE INAPPROPRIATE SHOCK. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR [RV] LEAD HAD HIGH IMPEDANCE MEASUREMENTS, WAS NOT SENSING APPROPRIATELY, NOISE WAS PRESENT AND A LEAD FRACTURE WAS SUSPECTED. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4396 IMPLANTABLE PACING LEAD