BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12857381 · Received November 22, 2021

    Report

    Report Number
    3006630150-2021-06639
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    September 9, 2021
    Report Date
    December 28, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED 6 WEEKS AGO FROM THE APPOINTMENT DATE (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7088817/7091393.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG AND MIDLINE INCISION SITE. IT WAS ALSO NOTED THAT THE PATIENT LOSS COVERAGE ON THE LEFT LEG PAIN DESPITE REPROGRAMMING ATTEMPT. X-RAY REVEALED THAT THE LEAD HAD MIGRATED. PATIENT HAD TOPICAL CREAMS OR LIDOCAINE PATCHES OVER THE AREA WITH NO RELIEF. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG AND MIDLINE INCISION SITES. PATIENT HAD TOPICAL CREAMS OR LIDOCAINE PATCHES OVER THE AREA WITH NO RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751249 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 508951 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention