BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21906942 · Received April 25, 2025

    Report

    Report Number
    3006630150-2025-02770
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    January 30, 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
    CO, 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-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7073386. UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138250 MODEL: SC-3138-25 SERIAL: (B)(6). BATCH: 7073533. UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7073564. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATION (IPG) WAS RELOCATED, AND LEAD EXTENSIONS WERE REPLACED. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE IPG REMAINS IMPLANTED, AND THE EXPLANTED EXTENSIONS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503055 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 750898 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention