BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4970666 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08416
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. 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 OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). A TOTAL OF 24 NON-SUSTAINED TACHYCARDIA (NST)EPISODES WITH V-V INTERVALS <(><<)> 220 MS OCCURRED BETWEEN (B)(6) 2015. APPARENT NOISE OVERSENSING SEEN ON ELECTROGRAMS OF NST EPISODES. LEAD FAILURE PREDICTOR TRIGGERED ON (B)(6) 2015 FOR VENTRICULAR SICS AND HIGH RATE NON-SUSTAINED EPISODES. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. RV PACE IMPEDANCES STEADY AT APPROXIMATELY 400 OHMS THROUGH (B)(6) 2015, RISES OUT OF RANGE (>3000 OHMS) STARTING (B)(6) 2015. AN ALERT FOR OUT OF RANGE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2015. CONCOMITANT PRODUCT: 419678 LEAD, IMPLANTED: (B)(6) 2014; DTBB1D1 ICD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE, NOISE NOTED ON THE ELECTROGRAMS, AND A FRACTURE WAS CONFIRMED. THE LEAD WAS CAPPED AND REPLACED. THE LEFT VENTRICULAR LEAD WAS ALSO NOTED TO BE DISLODGED. THE LEAD WAS EXPLANTED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514177 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R 5076-52 LEAD