BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1792311 · Received August 10, 2010

    Report

    Report Number
    2182208-2010-00443
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 3, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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) PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED THE RV MAX IMPEDANCE MEASUREMENT WAS VARIABLE OVER THE DURATION OF THE RECORD RANGING FROM 1456 - 1904 OHMS. THE DATA ALSO SHOWED NOISE. THE VENTRICULAR SENSING INTEGRITY COUNTER IS 531 AND ALL BUT 25 OF THESE COUNTS OCCURRED SINCE (B)(6) 2010. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE OCCASIONALLY INCREASED FROM 1500 TO 1800 OHMS, AND THERE WAS OVERSENSING. THE LEAD IS STILL 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 4592 IMPLANTABLE PACING LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB