BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 17530228 · Received August 12, 2023

    Report

    Report Number
    MW5137148
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    August 20, 2013
    Report Date
    August 28, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NVZ
    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 IPG. THE INFORMATION RECEIVED STATED THAT THE PATIENT'S MEDTRONIC IPG WAS EXPLANTED DUE TO CHARGING DIFFICULTIES. THE EXPLANT OCCURRED AT CALLOWAY CREEK SURGERY CENTER. (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
    727745 PULSE GENERATOR, PERMANENT, IMPLANTABLE PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown