BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24756413 · Received April 1, 2026

    Report

    Report Number
    3006630150-2026-01979
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    December 16, 2025
    Report Date
    April 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-9208-15. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7027288. MODEL/CATALOG DESCRIPTION: PRECISION S8 ADAPTER 15CM. UNIQUE IDENTIFIER (UDI):(B)(4). MODEL NUMBER/CATALOG NUMBER: SC-9208-15. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7070134. MODEL/CATALOG DESCRIPTION: PRECISION S8 ADAPTER 15CM. UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DESPITE OF OPTIMIZING THE PROGRAM, THE PATIENT EXPERIENCED INADEQUATE STIMULATION, BURNING SENSATION AND PAIN AT THE LOWER BACK. THREE ELEVATED IMPEDANCES WERE NOTED AND THE PHYSICIAN SUSPECTED IT WAS DUE TO S8 ADAPTER CONNECTION SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED WITH MRI CAPABLE DEVICE AND ONE OF THE ADAPTERS WAS REPLACED TO CLEAR IMPEDANCES. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816349 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 367314 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention