BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADDLE LEAD

    MDR report key: 17531481 · Received August 12, 2023

    Report

    Report Number
    MW5138396
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 18, 2013
    Report Date
    October 23, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED INFORMATION ABOUT AN EVENT ON (B)(6) 2013 THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. HOWEVER, THE ISSUE REPORTED WAS RELATED TO A MEDTRONIC PADDLE LEAD. THE INFORMATION RECEIVED STATED THAT THE PATIENT'S MEDTRONIC LEAD WILL BE EXPLANTED DUE TO A SUSPECTED FRACTURE. (B)(4). 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
    1085684 PADDLE LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown