BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1861575 · Received October 8, 2010

    Report

    Report Number
    2182208-2010-00718
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 9, 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
    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 THE SENSING INTEGRITY COUNT(SIC) IS ELEVATED AND THERE ARE MULTIPLE NON SUSTAINED TACHYCARDIA(NST) EPISODES, THAT TRIGGERED LEAD INTEGRITY ALERT(LIA).THE EGM FOR THE NST EPISODES SHOW RANDOM NOISE IN SHORT BURSTS AT VARIOUS TIMES DURING THE DAY. THE PATIENT IS NON-SYMPTOMATIC AND AWARE OF ONLY ALERT TONES. THE LEAD HAS BEEN REPLACED. 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. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4524 IMPLANTABLE PACING LEAD