BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 7856759 · Received September 7, 2018

    Report

    Report Number
    2182208-2018-01641
    Event Type
    Death
    Date Received
    September 7, 2018
    Date of Event
    March 20, 2018
    Report Date
    September 7, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/SERIAL NUMBERS. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 63 YEARS OLD. 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:BETA-BLOCKER THERAPY IS ASSOCIATED WITH A LOWER INCIDENCE OF SYNCOPE DUE TO FAST VENTRICULAR TACHYCARDIAS AMONG IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION: RESULTS FROM A MULTICENTER STUDY. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2018; 52(1):69-76.10.1007/S10840-018-0344-0. 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 CARDIOVERTER DEFIBRILLATORS (ICDS). THE AIM OF THE STUDY WAS TO DETERMINE IF BETABLOCKERS COULD REDUCE THE OCCURRENCE OF SYNCOPE DUE TO FAST VENTRICULAR TACHYCARDIA. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS PATIENT DEATHS AND PATIENTS THAT EXPERIENCED INAPPROPRIATE THERAPY. THE AUTHOR STATES THE INAPPROPRIATE THERAPY WAS DUE TO ATRIAL FIBRILLATION/TACHYCARDIA, LEAD FRACTURE, OR T WAVE OVERSENSING. THE STATUS OF THE LEADS AND DEVICES IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698508 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| L| R MDT-LEAD