BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN LEAD

    MDR report key: 19269589 · Received May 8, 2024

    Report

    Report Number
    MW5154658
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 7, 2024
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS GETTING A SYSTEM EXTRACTION DUE TO POCKET INFECTION. PATIENT PRESENTED TO HIS CARDIOLOGY OFFICE WITH THE DEVICE PROTRUDING FROM HIS SKIN. TISSUE AND LEAD SAMPLES WERE COLLECTED AND SENT FOR PATHOLOGY TESTING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT: MW5154659.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357931 SELECTSECURE MRI SURESCAN LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown