BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 14273675 · Received May 4, 2022

    Report

    Report Number
    2182208-2022-01390
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    January 1, 2021
    Report Date
    May 2, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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 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: SAFETY OF LEAD REPAIR COMPARED TO LEAD REVISION FOR VISIBLE LEAD INSULATION DEFECTS IN PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES. CANADIAN JOURNAL OF CARDIOLOGY (CJC) OPEN 3 (2021) 1490E1494. DOI:10.1016/J.CJCO.2021.07.019. 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 LEADS WITH INSULATION DEFECTS. THE ARTICLE REPORTS LEADS WHICH WERE REPAIRED OR REVISED DUE TO INSULATION ISSUES. POST REPAIR OR REVISION, THERE WERE LEADS WHICH DISLODGED AND REQUIRED REPOSITIONING, A RECURRENCE OF LEAD DYSFUNCTIONS WHICH REQUIRED LEAD REVISION, AND ONE CASE OF LEAD ENDOCARDITIS WHICH OCCURRED SEVEN YEARS POST LEAD REVISION. THE STATUS/DISPOSITION OF THE LEADS 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
    1243535 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H UNKNOWN COMPETITOR IPG, ICD.