BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153683 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01461
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 20, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD BEEN RISING STEADILY SINCE IMPLANT SIX WEEKS AGO AND WAS NOW HIGH. AN ALERT TRIGGERED. IT WAS ALSO REPORTED THAT THERE WAS NOISE ON THE LEAD AND A CONNECTION ISSUE WAS SUSPECTED. NO FURTHER INFORMATION COULD BE OBTAINED. THE LEAD REMAINS 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
    254401 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG 6947

    Patients

    Seq Age Sex Outcome Treatment
    1