BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4162988 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12531
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THE MAXIMUM DEFIBRILLATION ACTIVE CAN IMPEDANCE ROSE FROM 83 TO 111 OHMS THE WEEK ENDING 2014-(B)(6). HIGH IMPEDANCE ALERTS WERE TRIGGERED ON 2014-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HIGH VOLTAGE COIL IMPEDANCE HAD TWO HIGH IMPEDANCE MEASUREMENTS AND THEN RETURNED TO A BASELINE OF ABOUT 75 OHMS; AN ALERT WAS TRIGGERED EACH TIME. THE ALERT TRIGGER WAS REPROGRAMMED TO A HIGHER VALUE, ISOMETRICS AND AN X-RAY WERE SUGGESTED AND 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
    639367 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR DTBA1D4 ICD, 5076-45 LEAD, 1258T LEAD