BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3152640 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06717
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED AT HOME WHILE WORKING WITH A HAMMER IN HIS HOUSE. A DEVICE CHECK REVEALED THAT ANTI-TACHY PACING (ATP) AND TWO SHOCKS WERE DELIVERED DUE TO TWAVE OVERSENSING. CHANGING THE RIGHT VENTRICULAR LEAD SENSITIVITY OR SENSING POLARITY WAS DISCUSSED. THE LEAD 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
    252063 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Life Threatening| R