BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 21886673 · Received April 22, 2025

    Report

    Report Number
    3006630150-2025-02688
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    March 28, 2025
    Report Date
    June 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: M365SC2218500 MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7071718/7071668, UDI: ((B)(4), UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43160, MODEL: SC-4316, BATCH: 24510909, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR EXPLANT WAS PATIENTS PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727380 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 363930 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention