BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2791014 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14487
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 9, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IT WAS NOTED THE RESISTANCE/IMPEDANCE WAS HIGH. THERE IS ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN INCREASE FOR MINIMUM AND MAXIMUM VENTRICULAR PACE BIPOLAR IMPEDANCE EQUAL TO 950 TO 1672 OHMS PEAK BETWEEN (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT JUMPED OFF THE BACK OF A TRUCK AND A LEAD ALERT WAS GENERATED FOR RIGHT VENTRICULAR LEAD IMPEDANCE HIGH. DAILY LEAD IMPEDANCES WERE ALSO FOUND TO BE HIGH. FURTHER TESTING WAS RECOMMENDED. REPROGRAMMING WAS DONE AND THE LEAD REMAINS IN USE NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS ALSO A RISE IN PACING THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 5554 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB