BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 24340060 · Received February 13, 2026

    Report

    Report Number
    3006630150-2026-00898
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    February 1, 2025
    Report Date
    February 13, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO MONTHS AFTER IMPLANT PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7097949, UPN: M365SC2218700, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7092348, UPN: M365SC2218700, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOTH INADEQUATE AND OVER STIMULATION CAUSING THE PATIENT TO FURTHER EXPERIENCE DIFFERENT SYMPTOMS SUCH AS PAIN AT THE POCKET SITE, TINGLING SENSATION, WEAKNESS AND HYPERSENSITIVITY. THE PATIENT UNDERWENT A SCS EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401072 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 225825 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention