BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3993751 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09140
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, THERE WAS A LEAD IMPEDANCE OUT OF RANGE ALERT, AND THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING. THERE WAS GRADUALLY RISING IMPEDANCE FROM 898 OHMS TO 4047 OHMS. DURING THE WEEK OF 05JUN2014, RV PACING IMPEDANCE MEASURED 4047 OHMS, UP FROM 1406 OHMS THE WEEK PREVIOUS. AN RV LEAD INTEGRITY WARNING OCCURRED 30MAY2014 FOR LEAD FAILURE PREDICTOR.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 5076 LEAD IMPLANTED: 2003 (B)(6); 4193 LEAD IMPLANTED: 2003 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE AND THERE WERE STORED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES WHICH SHOWED NOISE ON THE LEAD. FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467365 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694465

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R (B)(4) ICD