BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ICD

    MDR report key: 10103480 · Received May 29, 2020

    Report

    Report Number
    2182208-2020-00987
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    January 1, 2019
    Report Date
    May 29, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. OF NOTE, MULTIPLE PA TIENTS/MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS/MANUFACTURERS. THE OVERALL BASELINE GENDER CHARACTERISTICS IS MALE; THE AGE OF THE PATIENTS WAS 60 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿VENTRICULAR TACHYCARDIA IN NONISCHEMIC CARDIOMYOPATHY: ANTEROSEPTAL VS INFEROLATERAL ORIGIN BASED ON ICD VENTRICULAR ELECTROGRAM TIMING.¿ JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2019; 30(11):2334-2343. DOI: 10.1111/JCE.14135. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATIONS WHILE USING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD): THERE WERE TWO (2) PATIENTS WHO EXPERIENCED PERICARDIAL EFFUSIONS, BOTH OF WHICH REQUIRED DRAINAGE. THERE WAS ONE (1) PATIENT WHO EXPERIENCED A GROIN HEMATOMA, WITH UNKNOWN TREATMENT/RESOLUTION. THERE WAS ONE (1) PATIENT WHO HAD ¿SUCCESSFUL¿ RESUSCITATION AFTER PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST; OF NOTE, THERE WERE NO RESIDUAL COMPLICATIONS FOR THIS PATIENT. OF NOTE, MULTIPLE PATIENTS/MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS/MANUFACTURERS. THE STATUS/LOCATION OF THE DEVICE IS UNKNOWN. 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
    565271 MEDTRONIC ICD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R