BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 22290147 · Received June 19, 2025

    Report

    Report Number
    3006630150-2025-04676
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    December 25, 2024
    Report Date
    June 19, 2025
    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
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5130371, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5130231, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT IMPLANTABLE PULSE GENERATOR (IPG) CHARGING AND INADEQUATE STIMULATION ISSUES. THE PATIENTS LEADS ALSO HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REVISION PROCEDURE. NO FURTHER INFORMATION WAS OBTAINED DESPITE MULTIPLE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788952 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 350000 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention