BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16309276 · Received February 6, 2023

    Report

    Report Number
    3006630150-2023-00431
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    October 27, 2022
    Report Date
    February 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: (B)(4). MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7080315/7085979.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS EXACERBATING THE PATIENTS PAIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114592 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 541219 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention