BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4160657 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02816
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. CONCOMITANT MEDICAL PRODUCTS: D154AWG ICD, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE, LEADING TO OVERSENSING ABOUT TWENTY MINUTES AFTER A ROUTINE DEVICE CHANGE OUT. THE LEAD OVERSENSING WAS REPRODUCIBLE. IT WAS NOTED THAT AFTER THE DEVICE WAS CHANGED OUT THE DFT (DEFIBRILLATION THRESHOLD) TESTING WAS PERFORMED AND EVERYTHING WAS NORMAL. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641552 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 5076-52 LEAD