BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 14488295 · Received May 24, 2022

    Report

    Report Number
    3006630150-2022-02417
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    June 21, 2021
    Report Date
    May 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED DURING TRIAL.

    Additional Manufacturer Narrative · 0

    H10 SHOULD HAVE BEEN: ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7093384 / 7093390 / 7093423.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE REPROGRAMMING DONG. THE PATIENT UNDERWENT EXPLANT PROCEDURE AND THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE REPROGRAMMING DONG. THE PATIENT UNDERWENT EXPLANT PROCEDURE AND THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473948 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 510252 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention