BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 4895700 · Received July 7, 2015

    Report

    Report Number
    2182208-2015-02212
    Event Type
    Death
    Date Received
    July 7, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THE EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO DIRECT CORRELATION WITH A DEVICE SERIAL NUMBER. THE PATIENT DEATH REFERENCE HAS NO DIRECT CORRELATION WITH A DEVICE SERIAL NUMBER. MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEVICE/PRODUCT FAILURE CORRELATION OR DEATH-DEVICE RELATEDNESS INDICATED. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE IDS WERE PROVIDED, IT IS UNKNOWN IF ANY OF THE REPORTED EVENTS HAVE BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: THE CLINICAL COURSE OF PATIENTS WITH IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS: EXTENDED EXPERIENCE ON CLINICAL OUTCOME, DEVICE REPLACEMENTS, AND DEVICE-RELATED COMPLICATIONS. HEART RHYTHM. 2015;12(6):1169-1176. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE DISCUSSING EXPERIENCE WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD), CARDIAC RESYNCHRONIZATION THERAPY- DEFIBRILLATORS (CRT-D), AND LEADS WAS REVIEWED. IT CONTAINED REFERENCES TO PATIENT DEATHS, INAPPROPRIATE SHOCKS, LEAD MALFUNCTIONS, AND INFECTION. MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEVICE/PRODUCT FAILURE CORRELATION OR DEATH-DEVICE RELATEDNESS INDICATED. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE BUT A DIRECT CORRELATION TO SPECIFIC DEVICE SERIAL NUMBERS COULD NOT BE MADE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439955 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death| H| L| R