BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20577916 · Received October 31, 2024

    Report

    Report Number
    3006630150-2024-07443
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: (B)(4). MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7079565/7081102/7081316.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION BEHIND THE LEFT EAR. THE PHYSICIAN DOES NOT BELIEVE THAT INFECTION WAS DEVICE RELATED. SINCE THE INFECTION WAS FAR TOO DEVELOPED, ALL COMPONENTS OF THE SPINAL CORD STIMULATION (SCS) SYSTEM WERE EXPLANTED AND DISCARDED, AS IT WAS NOT POSSIBLE FOR THE PHYSICIAN TO DEBRIDE THE INFECTION AND SALVAGE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011382 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 756460 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention