BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3160434 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07970
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE LEAD WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER), VENTRICULAR SIC WAS EQUAL TO 152 COUNTS, IN 1.77 DAYS, 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 HAD RECEIVED A SHOCK FOR VENTRICULAR FIBRILLATION. TWO DAYS LATER, THE RIGHT VENTRICULAR LEAD WAS NOTED TO HAVE OVERSENSING AS THERE WERE A NUMBER OF SHORT INTERVAL COUNTS (SIC). IT WAS FURTHER REPORTED THAT THE R-WAVE SENSING MEASUREMENTS HAD SIGNIFICANTLY DECREASED AND THERE WAS A DECREASE IN IMPEDANCE. A LEAD REVISION WAS SCHEDULED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260537 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R D364VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR