BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 17522832 · Received August 12, 2023

    Report

    Report Number
    MW5129780
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 18, 2011
    Report Date
    November 3, 2011
    Manufacturer
    PACESETTER
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LEAD WAS IMPLANTED ON (B)(6) 2000 AND WAS CAPPED ON (B)(6) 2011 DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. THE PHYSICIAN WAS DR. ELI GANG AT CEDARS SINAI MEDICAL CENTER IN (B)(6) CA. 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
    764024 UNKNOWN PERMANENT PACEMAKER ELECTRODE DTB PACESETTER 1388T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown