BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ICD

    MDR report key: 9507663 · Received December 20, 2019

    Report

    Report Number
    2182208-2019-02347
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    January 1, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/(B)(6) YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THE PMA NUMBER FOR THIS REPORT IS LISTED AS P900061 REFERENCED ARTICLE: SUBCLINICAL ATRIAL FIBRILLATION DETECTION WITH A FLOATING ATRIAL SENSING DIPOLE IN SINGLE LEAD IMPLANTABLE CARDI OVERTER-DEFIBRILLATOR SYSTEMS: RESULTS OF THE SENSE TRIAL JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2019; 30(10):1994-2001. 10.1111/JCE.14081. 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 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). THE AUTHORS WROTE THERE WERE FIVE PATIENTS THAT RECEIVED INAPPROPRIATE SHOCKS, ONE PATIENT DEVELOPED A PNEUMOTHORAX, ONE PATIENT REQUIRED EVACUATION OF A HEMATOMA, TWO PATIENTS DEVELOPED AN INFECTION AND TWO PATIENTS DEVELOPED DEEP VEIN THROMBOSES. 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
    1296555 MEDTRONIC ICD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R