BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN LEAD

    MDR report key: 11681178 · Received April 16, 2021

    Report

    Report Number
    2182208-2021-01523
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    January 1, 2020
    Report Date
    April 16, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P120017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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 OVERALL BASELINE GENDER CHARACTERISTICS IS MALE; THE AGE OF THE PATIENTS WAS APPROXIMATELY (B)(6). 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 LOT/SERIAL NUMBERS. 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. UPON RECEIPT OF ADDITIONAL INFORMATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: CARDIAC RESYNCHRONIZATION THERAPY WITH INTRAOPERATIVE EPICARDIAL MAPPING VIA MINITHORACOTOMY: 10 YEARS¿ EXPERIENCE. PACING AND CLINICAL ELECTROPHYSIOLOGY. 2021. 44:101¿109. DOI: 10.1111/PACE.14123. 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT VIA MINI THORACOTOMY. THE ARTICLE REPORTS PATIENTS THAT EXPERIENCED VENTRICULAR FIBRILLATION (VF) DURING THE IMPLANT PROCEDURE AND WERE SUCCESSFULLY DEFIBRILLATED. THERE WAS ALSO ONE PATIENT THAT HAD A POCKET INFECTION, THE LEAD WAS REMOVED. 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
    578017 SCREW-IN LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R UNKNOWN COMPETITOR CRT