BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2811475 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03760
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: "INAPPROPRIATE ICD SHOCKS CAUSED BY T-WAVE OVERSENSING DUE TO ACUTE ALCOHOL INTOXICATION." PACE PACING CLIN. ELECTROPHYSICAL. (B)(4) 2012; 35(9):E267-E271.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION ABOUT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATION (ICD) SYSTEM. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AFTER RECEIVING THREE ICD SHOCKS WHILE AT HOME WATCHING TELEVISION. THE PATIENT ALSO COMPLAINED OF ABDOMINAL PAIN, NAUSEA, VOMITING, AND DIARRHEA DURING THE PAST FEW DAYS. THE PATIENT HAD A HISTORY OF ALCOHOLISM AND RECENT BINGE-DRINKING. WHILE IN THE HOSPITAL, THE PATIENT RECEIVED ADDITIONAL INAPPROPRIATE THERAPIES WHILE IN SINUS RHYTHM. THERE WERE NO SYMPTOMS PRIOR OR FOLLOWING THE SHOCKS. DEVICE INTERROGATION SHOWED T-WAVE OVERSENSING. AN ECHOCARDIOGRAM REVEALED LOW EJECTION FRACTION, BUT NO SIGNIFICANT CHANGES FROM THE ELECTROCARDIOGRAM OBTAINED TWO YEARS PRIOR. CONTINUED IN OTHER DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R