BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3160457 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08047
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY:THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED; 13 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF <(><<)>=210 MS OCCURRED BETWEEN (B)(6) 2012 AND (B)(6) 2013; 10 VENTRICULAR FIBRILLATION (VF) EPISODES <(><<)>=200 MS AVERAGE V-CYCLE OCCURRED BETWEEN (B)(6) 2012 AND (B)(6) 2013. CONCOMITANT PRODUCTS: D154VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED SEVERAL EPISODES OF T-WAVE OVERSENSING (TWOS). THE PATIENT RECEIVED UNNECESSARY THERAPY. THE LEAD WAS PROGRAMMED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259425 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R