BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 24714515 · Received March 30, 2026

    Report

    Report Number
    3006630150-2026-01852
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 11, 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
    US
    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-2317-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5091252, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM, UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5089152, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM, UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619702 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 203594 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention