BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 8405879 · Received March 8, 2019

    Report

    Report Number
    2182208-2019-00484
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    September 29, 2018
    Report Date
    March 8, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. 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. MULTIPLE PATIENTS AND ¿ALL FIVE RELEVANT MANUFACTURERS¿ WERE STATED IN THE ARTICLE AND A ONE TO ONE CORRELATION CANNOT BE MADE. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/61 YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: DEFENSIVE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR PROGRAMMING IS SAFE AND REDUCES INAPPROPRIATE THERAPY: COMPARISON OF 3 PROGRAMMING STRATEGIES IN 1,471 PATIENTS. CIRCULATION JOURNAL 82 (12): 2976-2982. DOI: 10.1253/CIRCJ.CJ-18-0611. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD), CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D), INAPPROPRIATE SHOCKS, INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP), AND PROGRAMMING STRATEGIES. THE AUTHORS DISCUSSED THE NUMBER OF PATIENTS THAT RECEIVED INAPPROPRIATE SHOCKS/ATP AND COMPARED THIS TO THREE CATEGORY SETTINGS. ADDITIONALLY, THE ARTICLE SHOWED THERE WERE ¿ALL CAUSE DEATHS.¿ THE STATUS/DISPOSITION OF THE DEVICES IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199464 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening