BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 24772023 · Received April 2, 2026

    Report

    Report Number
    3006630150-2026-02031
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 2, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED AFTER IMPLANT PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8216-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080542 MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 50 CM UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829578 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 244812 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention