BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 1874978 · Received October 19, 2010

    Report

    Report Number
    2182208-2010-00837
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THERE WAS A SUDDEN INCREASE IN SVC IMPEDANCE TO GREATER THAN 200 OHMS, AND THE PATIENT ALERT SOUNDED. ALSO REPORTED WAS THAT THE LEAD SHOWED OVERSENSING AND AN ELEVATED SENSING INTEGRITY COUNT. EXTERNAL EMI IS ALSO SUSPECTED. THE LEAD REMAINS 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD