BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21914941 · Received April 25, 2025

    Report

    Report Number
    3006630150-2025-02826
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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: 7121460/7121706, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7090778/7090856, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE IT WAS NOTICED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAD PULLED OUT OF THE EPIDURAL SPACE. THE PHYSICIAN DECIDED TO EXPLANT THE SCS SYSTEM. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811863 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 565149 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention