BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1863372 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11339
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    August 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIPPED DUE TO AN SHORT INTERVAL COUNT (SIC) OF 632 SINCE (B)(6) 2010 AND NST EPISODES. THE EPISODES REVEALED T-WAVE OVERSENSING (TWOS). NO OBSERVABLE SENSING ISSUES CAN BE SEEN REAL-TIME AND THE IMPEDANCE TREND HAS REPORTEDLY BEEN STABLE. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB