BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTABLE NEUROSTIMULATION SYSTEM

    MDR report key: 18949580 · Received March 20, 2024

    Report

    Report Number
    MW5153036
    Event Type
    Other
    Date Received
    March 20, 2024
    Report Date
    March 19, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    GZB
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT SAID SHE IS HAVING ISSUES WITH THE GENERATOR. IT IS TELLING HER SHE NEEDS TO REPLACE THE GENERATOR AND GENERATOR IS NOT WORKING (B)(6). PATIENT SAID HER REPRESENTATIVE WAS (B)(6) AND DR. (B)(6) WAS THE DOCTOR THAT INSTALLED THE SYSTEM. PT DID NOT HAVE MDT EQUIPMENT AND WAS REDIRECTED TO ABBOTT. 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
    2317383 IMPLANTABLE NEUROSTIMULATION SYSTEM STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown