BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 1922940 · Received December 13, 2010

    Report

    Report Number
    2182208-2010-00960
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 6, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 RIGHT VENTRICULAR LEAD IMPEDANCE WAS OUT OF RANGE. DUE TO THIS THE LEAD INTEGRITY ALERT TRIGGERED. 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
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6940 IMPLANTABLE PACING LEAD