BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20252448 · Received September 18, 2024

    Report

    Report Number
    3006630150-2024-06233
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 16533324. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 16536642/7075107/7075120. PRODUCT FAMILY: SCS-SPLITTERS. UPN: M365SC3354250. MODEL: SC-3354-25. SERIAL: (B)(6). BATCH: 7070094.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A FULL SPINAL CORD STIMULATION EXPLANT PROCEDURE DUE TO INFECTION. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532842 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 542915 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention