BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 12599994 · Received October 8, 2021

    Report

    Report Number
    2182208-2021-04017
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    January 9, 2021
    Report Date
    October 8, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. 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: TRANSVENOUS PACING THROUGH THE PULMONARY VALVE IN A PATIENT WITH CYANOTIC CONGENITAL HEART DISEASE AFTER GLENN SHUNT E A CASE REPORT. INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL. 21 (2021) 132-136. DOI.ORG/10.1016/J.IPEJ.2020.12.003. 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 THIS EPICARDIAL LEAD. THE ARTICLE REPORTS A PATIENT WHOSE LEAD EXHIBITED AN INCREASE IN THRESHOLDS TO HIGH VALUES. THE LEAD WAS EXPLANTED AND REPLACED. NO 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
    1496957 MEDTRONIC LEAD IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R MDT IPG