BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 5133599 · Received October 7, 2015

    Report

    Report Number
    2649622-2015-10699
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 20, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4). PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT TRIGGERED. IT WAS NOTED BEGINNING (B)(4) 2015, 92 VENTRICULAR SIC WERE OBSERVED, ALONG WITH VENTRICULAR TACHYCARDIA (VT) NON-SUSTAINED (NS) AND HIGH RATE-NS EPISODES WITH EVIDENCE OF LEAD NOISE OVERSENSING. IT WAS ALSO NOTED ON (B)(4) 2015, THE RV LEAD PACING IMPEDANCE SPIKED TO >3000 OHMS UP FROM A TREND IN THE 400-500 OHM RANGE AND THE IMPEDANCES CONTINUED TO BE HIGH AND VARIABLE. THE RV LEAD INTEGRITY WARNING OCCURRED ON (B)(4) 2015 FOR 2 OR MORE HIGH RATE-NS EPISODES AND RV LEAD IMPEDANCE VARIATION IN LAST 60 DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA). THE RV LEAD EXHIBITED HIGH IMPEDANCE, HIGH THRESHOLDS, OVERSENSING OF SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA (NST) EPISODES, ALONG WITH A SUSPECTED LEAD FRACTURE. THE RV LEAD WAS EXPLANTED 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
    661965 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R