BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17715236 · Received September 8, 2023

    Report

    Report Number
    3006630150-2023-05424
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    April 14, 2023
    Report Date
    November 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1216 (SN: (B)(6)). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 0

    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: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7072179/7073264.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS CONCERNED THAT THE SPINAL CORD STIMULATOR WAS AFFECTING THEM MENTALLY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS CONCERNED THAT THE SPINAL CORD STIMULATOR WAS AFFECTING THEM MENTALLY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502461 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 541524 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention