BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 12962784 · Received December 8, 2021

    Report

    Report Number
    2182208-2021-04822
    Event Type
    Injury
    Date Received
    December 8, 2021
    Date of Event
    January 1, 2021
    Report Date
    December 8, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/60 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: SURVIVAL AFTER IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR SHOCKS. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 2021. 77(20):2453-2462. DOI.ORG/10.1016/J.JACC.2021.03.329 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING SURVIVAL AFTER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKS. THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED INAPPROPRIATE SHOCKS AND INAPPROPRIATE ANTI-TACHYCARDIA PACING WITH SOME PATIENTS ALSO HOSPITALIZED. THE INAPPROPRIATE THERAPY WAS DUE TO DEVICE DETECTION ISSUES, NOISE/OVERSENSING, MYOPOTENTIAL OVERSENSING, OR LEAD MALFUNCTIONS. THE STATUS/DISPOSITION OF THE DEVICES AND LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860131 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Life Threatening| H UNKNOWN ICD/CRT-D