BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 3993701 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09165
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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. CONCOMITANT: 419488 LEAD, IMPLANTED 2012-(B)(6), 6940-52 LEAD, IMPLANTED 2001-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INTEGRITY ALERT (LIA) TRIGGERED FOR ELEVATED SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA (NST) ON THE RIGHT VENTRICULAR (RV) LEAD. ELECTROGRAM INDICATED ELECTROMAGNETIC INTERFERENCE (EMI) NOISE WAS PRESENT ON BOTH THE RIGHT ATRIAL (RA) LEAD AND RV LEAD. IT WAS NOTED THAT, DURING THE EVENT, THE PATIENT WAS LAYING UNDERNEATH THE MOTORHOME WORKING ON THE EXHAUST SYSTEM WHILE THE AC WAS LIKELY RUNNING. 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
    467289 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR D314TRG ICD