BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 6152228 · Received December 7, 2016

    Report

    Report Number
    2182208-2016-02615
    Event Type
    Death
    Date Received
    December 7, 2016
    Date of Event
    August 14, 2001
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/67 YEARS OLD. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THERE ALSO IS NO SPECIFIC INFORMATION REGARDING THE MODELS; THE POSSIBLE INVOLVED MODELS THAT ARE REFERENCED IN THE ARTICLE ARE: 7221, 7223, 72227, 7271, 7229, AND 7273. 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿SHOCK REDUCTION USING ANTI-TACHYCARDIA PACING FOR SPONTANEOUS RAPID VENTRICULAR TACHYCARDIA IN PATIENTS WITH CORONARY ARTERY DISEASE.¿ CIRCULATION. 2001;104:796-801. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE LEADS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENT DEATHS OF UNKNOWN CAUSES IDENTIFIED. OF NOTE, THERE IS NO ALLEGATION/RELATEDNESS BETWEEN THE SYSTEM AND THE PATIENTS¿ DEATHS. THERE WERE ALSO PATIENTS WHO EXPERIENCED SYNCOPE, LIGHTHEADEDNESS, AND DIZZINESS. THE AUTHOR INDICATED THERE WERE SOME POSSIBLE ISSUES WITH THE ANTI-TACHYCARDIA PACING (ATP) FEATURE OF THE DEVICE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION AND ANY ADDITIONAL INFORMATION PERTAINING TO THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802233 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R