BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15492134 · Received September 27, 2022

    Report

    Report Number
    3006630150-2022-05055
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    June 17, 2022
    Report Date
    September 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI. UPN: M365SC8452700. MODEL: SC-8452-70. SERIAL: (B)(4). BATCH: 7070204.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT THE IPG SITE WITH SORENESS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICE WAS DISCARDED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273761 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 537023 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention