BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3861587 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07228
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCTS: 4194-88, LEAD, IMPLANTED (B)(6) 2010; D224TRK, ICD, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO A RIGHT VENTRICULAR LEAD FRACTURE. THE LEAD WAS OVERSENSING NOISE AND A LEAD INTEGRITY ALERT WAS TRIGGERED. 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
    342861 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R 4076-52 LEAD