BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810954 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16802
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY RECEIVED A SHOCK. THE PATIENT ALSO STATED THAT WHEN THE SYSTEM WAS CHECKED IN CLINIC, THEY WERE TOLD THAT THEY HAD SOME ARRHYTHMIAS FOR TWO TO THREE WEEKS LEADING UP TO THE SHOCK. ADDITIONALLY, THE PATIENT INQUIRED AS TO WHY THEY WERE NOT ALERTED PRIOR TO RECEIVING THE SHOCK. IT WAS LATER REPORTED BY THE PATIENT'S CLINIC THAT THE PATIENT HAS NOT BEEN SEEN SINCE RECEIVING THE SHOCK, THEY WERE UNAWARE THAT THE PATIENT RECEIVED A SHOCK, HAD NO AWARENESS OF POSSIBLE ARRHYTHMIAS AND DO NOT KNOW WHETHER THE SHOCK WAS APPROPRIATE OR INAPPROPRIATE. THE RIGHT VENTRICULAR [RV] 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
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB