BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992834 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09640
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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: D154AWG LEAD IMPLANTED: 2007-(B)(6). (B)(6)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE ER (EMERGENCY ROOM) AFTER RECEIVING FOUR SHOCKS AT HOME. WHILE IN THE WAITING ROOM THE PATIENT RECEIVED TWO MORE SHOCKS. IT WAS FOUND THAT RIGHT VENTRICULAR (RV) LEAD FRACTURE LEAD TO INAPPROPRIATE SHOCKS. ADDITIONALLY, OBSERVED ON ECGS WERE NON-PHYSIOLOGIC INTERVALS AND VENTRICULAR OVERSENSING OF ATRIAL PACING. THE RV 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
    471050 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| L| R 5076-52 LEAD