BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18107172 · Received November 9, 2023

    Report

    Report Number
    3006630150-2023-06904
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    June 1, 2023
    Report Date
    November 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: (B)(4). MODEL: SC-8336-70. SERIAL: (B)(4). BATCH: 7072814.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION SCS PATIENT WITH THE REFERENCED SPECTRA WAVEWRITER IMPLANTABLE PULSE GENERATOR IPG REPORTED BEING UNCOMFORTABLE WITH THE SCS SYSTEM IMPLANTED DUE TO HEATING ON THEIR SPINE. THE PATIENT REPORTED THAT THEY WERE REJECTED FOR A REPLACEMENT BECAUSE IT HAD BEEN ASSESSED THAT THE STIMULATOR WAS INTACT AND FUNCTIONING PROPERLY. IT WAS ALSO REPORTED THAT A MEETING WAS HELD WITH THE PATIENT, NEUROBIO THE LOCAL DISTRIBUTOR OF THIS SCS SYSTEM IN TURKEY, AND THE PATIENTS PHYSICIAN. THE PATIENT REPORTED THAT A REPRESENTATIVE FROM THE REGIONAL DISTRIBUTOR NEUROBIO DID NOT ACCEPT THE PATIENTS ALLEGATION THAT THE SYSTEM WAS DEFECTIVE DESPITE THE STIMULATOR AND ELECTRODES CAUSING HEATING ON THE PATIENTS SPINE AND BOTH HIPS, AND THAT THE PHYSICIAN STATED THEY WERE UNABLE TO MAKE ANY CHANGES TO THE SYSTEM UNLESS THE LOCAL DISTRIBUTOR ACCEPTED THAT THE STIMULATOR SYSTEM IS DEFECTIVE. THE PATIENT ALSO REPORTED THAT THEY WERE HOSPITALIZED DUE TO THE EXCESSIVE HEATING DESPITE CHARGING THE STIMULATOR FROM OUTSIDE THE BODY AS INSTRUCTED. NO CHANGES WERE MADE TO THE SYSTEM AND THE PATIENT REPORTED THAT THIS SITUATION CONTINUES TO AFFECT THEIR DAILY LIFE AND HEALTH SIGNIFICANTLY AND WANTS THE STIMULATOR AND ASSOCIATED LEADS TO BE REPLACED. THE PATIENT REPORTED THAT THE STIMULATOR IS CURRENTLY TURNED OFF AND THEY ARE UNABLE TO RETURN TO DAILY ACTIVITIES DUE TO SYMPTOMS FROM THEIR UNDERLYING MEDICAL CONDITIONS, WHICH INCLUDE REFLEX SYMPATHETIC DYSTROPHY, ALGO DYSTROPHY, AND NEUROPATHIC PAIN AS WELL AS THREE (3) SEVERE DISEASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804913 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 556177 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization