BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 24566420 · Received March 11, 2026

    Report

    Report Number
    3006630150-2026-01411
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    November 25, 2025
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7157903 / 7170303. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4316. BATCH/LOT NUMBER: 36963226. MODEL/CATALOG DESCRIPTION: CLIK ANCHOR. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS WOUND NEVER PROPERLY HEALED AND THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE RELATED AND NOTHING HAPPENED DURING A PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE INFECTION. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216300 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 242265 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention