BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21124562 · Received January 10, 2025

    Report

    Report Number
    3006630150-2024-09469
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 10, 2024
    Report Date
    January 10, 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
    TX, 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: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH: 7071092/7071150. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(6) BATCH: 7070576/7070628.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT ASPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION SUSPECTED. THE EXPLANTED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416549 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 362845 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention