BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3943587 · Received July 18, 2014

    Report

    Report Number
    2182208-2014-01851
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. THE REPORTED LEADS DID NOT REFERENCE A MANUFACTURE AND IT IS NOT KNOWN IF ANY OF THE INVOLVED LEADS WERE MEDTRONIC, INC. AND WILL NOT BE REPORTED. FOLLOW UP WILL BE CONDUCTED AND THE EVENT WILL BE UPDATED WITH ANY RELEVANT INFORMATION RECEIVED. REFERENCED ARTICLE: VENTRICULAR RATE MONITORING AS A TOOL TO PREDICT AND PREVENT ATRIAL FIBRILLATION-RELATED INAPPROPRIATE SHOCKS IN HEART FAILURE PATIENTS TREATED WITH CARDIAC RESYNCHRONISATION THERAPY DEFIBRILLATORS. HEART. 2014;100(11):848-854. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING ADVERSE EVENT AND FAILURE MODES: INAPPROPRIATE SHOCKS, . THE STATUS OF THE 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
    422883 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Life Threatening