BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3862161 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07035
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE IMPLANT ATTEMPT, THE LEAD PLACEMENT WAS DIFFICULT DUE TO TRICUSPID VALVE REGURGITATION. THE LEAD WAS REPOSITIONED MULTIPLE TIMES. AFTER THE 6TH OR 7TH ENGAGEMENT OF THE SCREW, THE LEAD IMPEDANCE MEASURED LOW. THE ELECTROGRAM SIGNAL ALSO CHANGED APPEARANCE. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. THE NEW LEAD HAD NORMAL FUNCTION IN A POSITION SIMILAR TO THE REPLACED LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341983 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR