BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 22951111 · Received September 3, 2025

    Report

    Report Number
    3006630150-2025-07146
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7101320, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7101411, UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATOR (SCS) LEADS WERE EXPLANTED. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734773 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 207102 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention