BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 1792390 · Received August 11, 2010

    Report

    Report Number
    2182208-2010-00446
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    September 1, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PACE SENSE IMPEDANCE WAS 700 OHMS SINCE IMPLANT, AND APPROXIMATELY EIGHT YEARS AND SIX MONTHS LATER, LEAD IMPEDANCE BEGAN STEADILY RISING UP TO 3000 OHMS, SUDDENLY DROPPED TO 1800 OHMS, AND CURRENTLY MAINTAINING AT 1700 OHMS. THERE WERE NO SIGNS OF OVERSENSING, BUT THERE WAS ONE NON-SUSTAINED TACHYCARDIA. HOWEVER, THERE WAS GOOD CAPTURE AND SENSING. THE DEVICE REMAINS ACTIVELY IMPLANTED WITH NO REPORT OF CONSEQUENTIAL ACTIONS. 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 29 YR Other 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD