BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2954435 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02280
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT PROCEDURE, OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR LEAD. THERE WAS ALSO LOSS OF CAPTURE NOTED ON TELEMETRY. A FEW DAYS LATER, THERE WAS A WARNING FOR HIGH LEAD IMPEDANCE. IT WAS ALSO REPORTED THAT THE INCREASING AND HIGH THRESHOLDS. THE LEAD ALERTS WERE TURNED OFF AND TACHY DETECTION WAS ALSO TURNED OFF. THE PACE/SENSE PORTION OF THE RV LEAD WAS LATER REPLACED WITH AN EXISTING LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58184 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR