BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 25180120 · Received May 15, 2026

    Report

    Report Number
    3006630150-2026-03161
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 20, 2023
    Report Date
    May 15, 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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THREE YEARS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. D6B: EXPLANT DATE: THREE YEARS AGO, FROM THE AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7091534 / 7091539. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291694 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 203204 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1