BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 10510971 · Received September 9, 2020

    Report

    Report Number
    2182208-2020-01800
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    January 1, 2019
    Report Date
    September 9, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. 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. THE OVERALL BASELINE AGE OF THE PATIENTS WAS 64 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. POSSIBLE MODELS COULD INCLUDE: 6944 OR 6947. 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: ¿PERFORMANCE OF THE LINOX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS: A SINGLE-CENTER EXPERIENCE.¿ PACE - PACING AND CLINICAL ELECTROPHYSIOLOGY. 2019; 42(12):1524-1528. DOI: 10.1111/PACE.13816. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PUBLICATION RECEIVED WAS A REVIEW COMPARING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS FROM MULTIPLE MANUFACTURERS. THERE WERE NO PATIENT/PRODUCT SPECIFICS REFERENCED FOR THIS MANUFACTURER; HOWEVER, THERE WERE NON-SPECIFIC ¿FAILURES¿ NOTED. THERE WAS NO INDICATION OF ANY TREATMENT/RESOLUTION. THE STATUS/DISPOSITION OF THE LEAD IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974566 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other