BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3862259 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06996
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), AND IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. 17 NON-SUSTAINED TACHYCARDIA (NST) EPISODES WITH V-V INTERVALS LESS THAN 220 MILLISECONDS OCCURRED BETWEEN (B)(6) 2014. 9 EPISODES WITH 230 MILLISECOND INTERVALS OCCURRED ON (B)(6) 2014. NUMEROUS VENTRICULAR SICS REVIEWED. THE LEAD FAILURE PREDICTOR TRIGGERED ON (B)(6) 2014 FOR VENTRICULAR SICS AND NST EPISODES. A SINGLE LOW IMPEDANCE MEASUREMENT OF 228 OHMS OCCURRED ON (B)(6) 2014. ALL OTHER IMPEDANCE MEASUREMENTS ARE WITHIN NORMAL LIMITS THROUGH LIFE OF TREND LINE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED WHETHER THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA (NST) EPISODES DUE TO NON-PHYSIOLOGIC NOISE. THERE WERE ALSO SHARP DROPS IN IMPEDANCE. A LEAD FAILURE PREDICTOR HAD TRIGGERED IN THE PAST DUE TO SIC AND NST. FRACTURE WAS SUSPECTED. THE LEAD WAS REPROGRAMMED AND SUBSEQUENTLY 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
    342460 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R D284VRC ICD