BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22815155 · Received August 15, 2025

    Report

    Report Number
    3006630150-2025-06525
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    April 26, 2025
    Report Date
    September 4, 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
    PA, 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-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7085947, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7082205, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT'S SPINAL STIMULATOR LEAD ALSO WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2687312 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 768075 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention