BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3862529 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06842
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 22, 2014
    Report Date
    March 25, 2014
    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

    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). ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD WARNING ALERT AND THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. 500 V-SIC ARE RECORDED BEGINNING (B)(4) 2014. AN RV PACE LEAD IMPEDANCE ALERT OCCURRED ON (B)(4) 2014. THERE ARE 29 VENTRICULAR FIBRILLATION (VF) AND 50 NON-SUSTAINED TACHYCARDIA (NST) EVENTS OF LESS THAN 220 MS V-V CYCLE RECORDED BETWEEN (B)(4) 2014.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ALSO HIGH IMPEDANCE AND POSSIBLE FRACTURE. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND REPLACED. THE HIGH VOLTAGE PORTION 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
    340585 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| L| R 7232CX LEAD