BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3861276 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07335
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. CONCOMITANT MEDICAL PRODUCTS: 7227CX ICD, IMPLANTED: (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE 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). THE ANALYST NOTED: THERE ARE 1268 V-SIC RECORDED, BEGINNING (B)(4) 2014. THERE ARE 23 NON SUSTAINED TACHYCARDIA AND 1 VENTRICULAR FIBRILLATION (VF) EVENTS OF <(><<)> 220 MS V-V CYCLE RECORDED BETWEEN (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS FURTHER REPORTED THAT WHEN THE DEVICE WAS REPLACED DUE TO APPROACHING ERI, THE RV LEAD FAILED A DEFIBRILLATION TEST ON THE REPLACEMENT DEVICE. THE DEVICE DETECTED VENTRICULAR FIBRILLATION (VF) BUT THE LEAD COULD NOT TERMINATE THE VF WITH TWO CONSECUTIVE SHOCKS. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339436 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| L| R D284VRC ICD