BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2941960 · Received February 4, 2013

    Report

    Report Number
    2649622-2013-00068
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 2, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    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. 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND A CONDUCTOR FRACTURED WAS FOUND. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED AN ABRUPT INCREASE FOR MAXIMUM VENTRICULAR PACING IMPEDANCE EQUAL TO 456 TO 1463 OHMS BETWEEN (B)(6) 2012 AND (B)(6) 2013. TWO VENTRICULAR NON-SUSTAINED TACHYCARDIA EVENTS LESS THAN OR EQUAL TO 160 MILLISECONDS ON (B)(6) 2013. FIVE LEAD FAILURE PREDICTORS WITH HIGH RATE NON-SUSTAINED EPISODES LESS THAN OR EQUAL TO 185 MILLISECONDS AVERAGE VENTRICULAR CYCLE BETWEEN (B)(6) 2013. THREE LEAD ALERTS FOR LEAD FAILURE PREDICTOR BETWEEN (B)(6) 2013.

    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 FELL ON THE STAIRS WHILE AT HOME AND THERE WAS REPORTED BLUNT TRAUMA TO THE DEVICE SITE. FOLLOWING THE FALL THE DEVICE BEGAN TO ALERT EVERY FOUR HOURS AND THE PATIENT WAS TAKEN TO THE HOSPITAL. THE ALERT WAS DETERMINED TO THE BE A LEAD INTEGRITY ALERT DUE TO THE RIGHT VENTRICULAR (RV) LEAD OVERSENSING WITH FAST NON-SUSTAINED VENTRICULAR TACHYCARDIA AND AN INCREASE IN THE PACE/SENSE IMPEDANCE. THE RV LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45789 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00005 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR