BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2811496 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16849
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 12, 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 Location
    PA, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. IMPEDANCE/HIGH IMPEDANCE: 1 - PATIENT ALERT FOR OOT SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 09:00:09. WEEKLY AND DAILY PACE LEAD IMPEDANCE TREND DATA SHOWS AN INCREASE FOR MIN AND MAX VENTRICULAR PACE BI = 893 TO 13040 OHMS PEAK BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT WAS TRIGGERED. IT WAS ALSO REPORTED THAT THERE WAS INCREASED RIGHT VENTRICULAR (RV) IMPEDANCE, HIGH RV IMPEDANCE AND HIGH RV THRESHOLD. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT WAS TRIGGERED. IT WAS ALSO REPORTED THAT THERE WAS INCREASED RIGHT VENTRICULAR (RV) IMPEDANCE, HIGH RV IMPEDANCE AND HIGH RV THRESHOLD. IT WAS FURTHER REPORTED THAT THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED, AND A NEW PACE/SENSE LEAD WAS IMPLANTED. THE HIGH VOLTAGE PORTION OF THE LEAD REMAINS 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB