BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 23822943 · Received December 16, 2025

    Report

    Report Number
    3006630150-2025-11486
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    August 22, 2025
    Report Date
    February 2, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 5094721. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5150230. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    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: 5094721, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5150230, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM WAS REVISED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCS SYSTEM WAS REPLACED DUE TO HIGH IMPEDANCES. ALTHOUGH THE HIGH IMPEDANCES DID NOT CAUSE ANY SYMPTOMS, THEY PREVENTED THE PATIENT FROM UNDERGOING A MAGNETIC RESONANCE IMAGING (MRI) SCAN. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED TO ENSURE MRI CONDITIONALITY. THE PATIENT UNDERWENT AN IPG AND LEADS REVISION PROCEDURE WHEREIN THE DEVICES WAS EXPLANTED AND REPLACED. THE DEVICES WERE DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT REPORTED NO COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM WAS REVISED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445037 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 352693 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention