BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21572932 · Received March 11, 2025

    Report

    Report Number
    3006630150-2025-01409
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    January 1, 2022
    Report Date
    March 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 5103012. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7072429.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO CHARGING DIFFICULTIES AND MAGNETIC RESONANCE IMAGING (MRI) PREFERENCES AND FOR HIGH IMPEDANCES ON THE LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THEIR IPG AND LEADS WERE EXPLANTED AND REPLACED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS. THE PATIENT IS DOING FANTASTIC POST OPERATIVELY, OBTAINED GREAT COVERAGE AND NO CHARGING ISSUES/IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337978 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 350902 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention