BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153492 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06051
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. PRODUCT EVENT SUMMARY: PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. IT WAS NOTED THERE WERE THREE PATIENT ALERTS FOR LEAD FAILURE PREDICTOR BETWEEN (B)(6) 2013 AND (B)(6) 2013. THE VENTRICULAR SHORT INTERVAL COUNT WAS 174 COUNTS IN 0.51 DAY ON (B)(6) 2013. THERE WERE 11 VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES WITH A CYCLE LENGTH OF LESS THAN OR EQUAL TO 210MS ON (B)(6) 2013. THERE WAS ALSO ONE VENTRICULAR FIBRILLATION EPISODE OF 180MS ON AVERAGE VENTRICULAR CYCLE ON (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SEEN FOR A ROUTINE DEVICE FOLLOW UP VISIT. WHEN THE PATIENT RAISED, THE LEFT ARM, LEAD NOISE WAS SEEN AND THE IMPEDANCE MEASUREMENT WAS HIGH. THE LEAD WAS ABANDONED AND A NEW LEAD WAS IMPLANTED. THE PHYSICIAN NOTED THE PORTION OF THE LEAD THAT WAS UNDERNEATH THE DEVICE WAS BENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258133 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R D294VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC