BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24658838 · Received March 22, 2026

    Report

    Report Number
    3006630150-2026-01696
    Event Type
    Injury
    Date Received
    March 22, 2026
    Date of Event
    February 26, 2025
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. D6B: EXPLANT DATE: A YEAR AGO FROM THE AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7072536, MODEL/CATALOG DESCRIPTION: OVEREDGE 32 SURGICAL LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65420 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 528679 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1