BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 6005455 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-11378
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 17, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY:THE DEVICE 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,AND THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS VARIABLE. BEGINNING (B)(6) 2016, RV PACING IMPEDANCE ROSE TO GREATER THAN 3000 OHMS UP FROM A TREND IN THE 285-418 OHM RANGE. IMPEDANCE VARIED BETWEEN 304-3000 OHMS. OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). BEGINNING (B)(6) 2016, VENTRICULAR SENSING INTEGRITY COUNTS UP TO 140; NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WITH EVIDENCE OF LEAD NOISE OVERSENSING.

    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 PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD SPIKING IMPEDANCE, NOISE, SENSING INTEGRITY COUNTER (SIC) AND A CONFIRMED FRACTURE. 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
    660562 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R