BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2813391 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17008
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN EPISODE IN THE VENTRICULAR TACHYCARDIA (VT) ZONE AND THERAPY WAS WITHHELD DUE TO THE DEVICE DISCRIMINATOR. IT WAS ALSO REPORTED THAT THE PHYSICIAN FELT IT WAS A VT. IT WAS FURTHER REPORTED THAT THERE WAS FAR FIELD R-WAVE (FFRW) PRIOR TO DETECTION. IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN OFF THEIR ANTIARRHYTHMICS DUE TO LACK OF INCOME TO OBTAIN THE MEDICINES AND THAT ARRHYTHMIAS OCCURRED DURING AN ACUTE MYOCARDIAL INFRACTION (MI) EPISODE IN THE EMERGENCY ROOM (ER.) THEREFORE THE VT DETECTION RATE WAS LOWERED AND HIGH RATE TIMEOUT WAS ENABLED. THE RIGHT VENTRICULAR (RV) LEAD AND DEVICE REMAIN IN USE. NO 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 55 YR Required Intervention 5076 IMPLANTABLE PACING LEAD