BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17481230 · Received August 8, 2023

    Report

    Report Number
    3006630150-2023-04613
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    December 28, 2022
    Report Date
    March 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY SEVERAL WEEKS ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    BLOCK D6B: EXPLANT DATE: 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6) , BATCH: 7100292/7095544.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATION (SCS) LEADS WERE ALSO EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPINAL CORD STIMULATION (SCS) LEADS WERE ALSO EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICES WERE NOT RETURNED AS NO BOSTON SCIENTIFIC REPRESENTATIVES WERE PRESENT DURING EXPLANT. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320385 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 527536 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention