BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 7076095 · Received December 1, 2017

    Report

    Report Number
    2182208-2017-01839
    Event Type
    Death
    Date Received
    December 1, 2017
    Date of Event
    March 15, 2017
    Report Date
    April 6, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. POSSIBLE MODELS COULD INCLUDE: PROTECTA XT ICD, PROTECTA XT CRT-D, EVERA XT ICD. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. 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 (B)(6). REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE:SUPERIOR RHYTHM DISCRIMINATION WITH THE SMARTSHOCK TECHNOLOGY ALGORITHM RESULTS OF THE IMPLANTABLE DEFIBRILLATOR WITH ENHANCED FEATURES AND SETTINGS FOR REDUCTION OF INACCURATE DETECTION (DEFENSE) TRIAL. CIRCULATION JOURNAL. 2017; 81(9):1272-1277. DOI: 10.1253/CIRCJ.CJ-16-1330.

    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 CARDIOVERTER DEFIBRILLATORS (ICD) AND CARDIAC RESYN CHROMIZATION THERAPY DEFIBRILLATORS (CRT-D) WITH A NEW DISCRIMINATION ALGORITHM. 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 PATIENTS DEATHS AND PATIENTS THAT EXPERIENCED INACCURATE DETECTION OF VENTRICULAR TACHYARRHYTHMIA,AND INAPPROPRIATE WITHHOLDING OF THERAPY. THE STATUS OF THE DEVICES IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    FOLLOW UP RECEIVED INDICATED NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856708 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| L