BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20871828 · Received December 6, 2024

    Report

    Report Number
    3006630150-2024-08545
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    March 14, 2022
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6); BATCH: 5133750. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2316700; MODEL: SC-2316-70; SERIAL: (B)(6); BATCH: 15734156/15813558.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATOR REPLACEMENT PROCEDURE WHERE ALL DEVICES WERE REPLACED. THE PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS NOT RELEASED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490287 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 351752 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention