BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3990657 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08552
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT MEDICAL PRODUCTS: D314DRG ICD, IMPLANTED (B)(6) 2013. (B)(4).

    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 NON-PHYSIOLOGIC OVERSENSING; THE SENSING INTEGRITY COUNTER WAS 13522 SINCE 2013-10-09. MULTIPLE EPISODES OF T WAVE OVERSENSING RESULTED IN THE INAPPROPRIATE THERAPY. A LEAD INTEGRITY WARNING OCCURRED ON 2014-02-23 FOR HIGH RATE NON-SUSTAINED TACHYCARDIA (NST) EPISODES AND ELEVATED SHORT INTERVAL COUNTS (SIC).

    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 EXPERIENCED TWO ANTI-TACHYCARDIA PACING (ATP) THERAPIES AND THREE SHOCKS DUE TO THE RIGHT VENTRICULAR LEAD OVERSENSING T WAVES. A LEAD INTEGRITY ALERT WAS TRIGGERED ABOUT THREE WEEKS PRIOR DUE TO HIGH RATE NON-SUSTAINED TACHYCARDIA EPISODES AND AN ELEVATED SHORT INTERVAL COUNTER AND THE STORED ELECTROGRAM SHOWED T WAVE OVERSENSING, HOWEVER, NO OVERSENSING OR NOISE WAS NOTED DURING ISOMETRICS OR POCKET MANIPULATION. THE LEAD IMPEDANCE AND THRESHOLD MEASUREMENTS WERE WITHIN NORMAL LIMITS AND SO THE SENSING POLARITY WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468361 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Hospitalization| L| R 4076-45 LEAD