BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3152066 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05548
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 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
    OTHER

    Narratives

    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. PRODUCT ID D384VRG, IMPLANTED: (B)(6) 2012. (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE DID NOT DELIVER THERAPY. THE PATIENT ARRIVED TO THE EMERGENCY DEPARTMENT ¿WITH ARREST;¿ THE PATIENT WAS EXPERIENCING VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION. EXTERNAL SHOCKS WERE GIVEN. T-WAVE OVERSENSING WAS ALSO NOTED ON THE ELECTROGRAM AND INTERVAL PLOT. THE PATIENT WAS ADMITTED TO INTENSIVE CARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252110 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| L| R