BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17526504 · Received August 12, 2023

    Report

    Report Number
    MW5133443
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    October 4, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON 10/04/2012 FROM SALES REP. THE LEAD WAS IMPLANTED ON (B)(6) 2004. THE LEAD WAS EXPLANTED DUE TO INFECTION. NO PHYSICIAN OR HOSPITAL KNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764256 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL 1688T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown