BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24565030 · Received March 10, 2026

    Report

    Report Number
    3006630150-2026-01406
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    February 12, 2026
    Report Date
    May 15, 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

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7070732. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER WORKING AS INTENDED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. THE PHYSICIAN PLUGGED THE SPINAL CORD STIMULATION (SCS) LEAD INTO THE NEW BATTERY AND LEARNED THAT THE INFINION LEAD HAD HIGH IMPEDANCES. THE LEAD WAS REMOVED AND REPLACED WITH TWO LINEAR LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO DEVICE WILL BE RETURNED DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424787 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 362162 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention