BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21821166 · Received April 10, 2025

    Report

    Report Number
    3006630150-2025-02371
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    February 28, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6) BATCH: 7102689/7102076. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO POSSIBLE INFECTION. SYMPTOMS OF SWELLING AND TENDERNESS AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE WERE NOTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351091 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 775161

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention