BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 9739894 · Received February 21, 2020

    Report

    Report Number
    2182208-2020-00340
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 1, 2019
    Report Date
    February 21, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. PLEASE SEE ATTACHED EXCEL SPREADSHEET FOR PATIENT/DEVICE/CONCLUSION CODES. 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: WHEN BIGGER IS BETTER: NOVEL USE OF A 27 F LEADLESS PACEMAKER DELIVERY SHEATH FOR FEMORAL LEAD EXTRACTIONS.¿ HEART RHYTHM. 2020; 17(1):152-157. 10.1016/J.HRTHM.2019.07.001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PACING LEADS. THE AUTHOR INDICATED THAT THERE WERE THREE PATIENTS WHO REQUIRED INTERVENTION. THE FOLLOWING COMPLICATIONS WERE NOTED: UNSPECIFIED LEAD MALFUNCTION, TWIDDLER¿S SYNDROME, ENDOCARDITIS/INFECTION, AND CAPPED LEAD REMOVAL. THE STATUS /LOCATION OF THE LEADS IS UNKNOWN. 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
    204667 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R