BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 25053630 · Received April 30, 2026

    Report

    Report Number
    3006630150-2026-02795
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2318-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5001559 MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 50CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2318-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 5001584 MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 50CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318 SERIAL NUMBER: BATCH/LOT NUMBER: 34808545 MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED TO THE HOSPITAL PRESENTING WITH EDEMA AND SWELLING, ACCOMPANIED BY SIGNIFICANT UNINTENTIONAL WEIGHT LOSS OVER SEVERAL POUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135053 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 227481 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention