BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15708487 · Received November 1, 2022

    Report

    Report Number
    3006630150-2022-05884
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(4). BATCH: 5131099/5131147. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(4). BATCH: 5023297/5058312.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ABLE TO PHYSICALLY FEEL THE LEADS UNDERNEATH THE SKIN WHEN LOOKING DOWN. THE PHYSICIAN BELIEVED THAT THE PATIENT WAS HAVING NEW PSYCHOLOGICAL ISSUES THAT NEEDED TO BE ADDRESSED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. NO DEVICE MALFUNCTION SUSPECTED. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458963 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 535674 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention