BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17823779 · Received September 27, 2023

    Report

    Report Number
    3006630150-2023-05873
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    December 15, 2022
    Report Date
    September 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL:(B)(6). BATCH: 7110402/7110232.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT PATIENT EXPERIENCED PAIN AND UNDESIRED SENSATION WHEN THE STIMULATOR WAS ON DESPITE MULTIPLE REPROGRAMMING DONE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973860 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 529703 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention