BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 9678515 · Received February 6, 2020

    Report

    Report Number
    2182208-2020-00240
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    October 1, 2009
    Report Date
    February 6, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US AND 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. REFERENCED ARTICLE: IMPACT OF LEFT VENTRICULAR PACING THRESHOLD ON VENTRICULAR ARRHYTHMIA OCCURRENCE IN CARDIAC RESYNCHRONIZATION THERAPY JOURNAL OF CARDIOLOGY. 2019; 74(4):353-359. 10.1016/J.JJCC.2019.03.015. 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 LEFT VENTRICULAR LEADS AND INTRA-OPERATIVE HIGH LEFT VENTRICULAR PACING THRESHOLDS (LVPT). THE AUTHORS CONDUCTED A STUDY WHICH SHOWED AN ASSOCIATION OF LVPT WITH REGIONAL MYOCARDIAL SCAR AND INCREASED RISK OF MALIGNANT TACHYARRHYTHMIAS. THERE WERE TWENTY-SEVEN PATIENTS THAT EXPERIENCED VENTRICULAR ARRYTHMIAS AND FIVE PATIENTS EXPERIENCED AN ELECTRICAL STORM. THE STATUS/DISPOSITION OF THE LEADS 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
    141444 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening