BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM III DR

    MDR report key: 3739228 · Received April 10, 2014

    Report

    Report Number
    2182208-2014-00718
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    November 5, 2013
    Report Date
    January 14, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    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. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. 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. THE EXACT IMPLANT DATE OF THE DEVICE IS UNKNOWN, HOWEVER THE YEAR IS VALID. REFERENCED ARTICLE: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND INAPPROPRIATE THERAPY: "BLACK BOX" EXAMINATION YIELDED BOTH HUMAN AND TECHNICAL CAUSES. CLIN. MED. INSIGHTS. CASE. REP. 2013;6:183-187. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS DEVICE. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THREE INAPPROPRIATE SHOCKS AFTER MODERATE EXERCISE. THE DEVICE WAS REPROGRAMMED WITH HIGHER DETECTION RATES AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216951 GEM III DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 7275

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Life Threatening| R