BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATION SYSTEM

    MDR report key: 17535501 · Received August 12, 2023

    Report

    Report Number
    MW5142397
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    November 18, 2021
    Report Date
    November 19, 2021
    Manufacturer
    UNKNOWN
    Product Code
    LGW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT HAD BAD STIM IN THEIR BACK AND THE CHARGING UNIT WAS NOT WORKING FOR THEM FOR THEY HAD TROUBLE. PATIENT SAID THEY HAD A NUVECTRA WITH SERIAL NUMBER (B)(6) AND MODEL 2413. PS REDIRECTED CALLER TO CALL NUVECTRA CUSTOMER SERVICE. PS DID NOT OBTAIN HCP OR EVENT DATE AS PT WAS NOT TRAINED ON DEVICE AND PT WAS WANTING TO GET OFF PHONE. (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
    729103 IMPLANTABLE NEUROSTIMULATION SYSTEM STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW UNKNOWN 2413

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown