BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22044328 · Received May 19, 2025

    Report

    Report Number
    3006630150-2025-03482
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 21, 2025
    Report Date
    July 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7099310/7102036, UDI: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS-MRI: UPN: M365SC8416500, MODEL: SC-8416-50, SERIAL: (B)(6), BATCH: 7078387, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT STARTED TAKING HER AUTOIMMUNE DRUG THAT SHE WAS INSTRUCTED NOT TO TAKE WHICH CAUSED THE IPG WOUND SITE TO BE COMPROMISED AND STARTED TO DRAIN AND OPEN UP. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT STARTED TAKING HER AUTOIMMUNE DRUG THAT SHE WAS INSTRUCTED NOT TO TAKE WHICH CAUSED THE IPG WOUND SITE TO BE COMPROMISED AND STARTED TO DRAIN AND OPEN UP. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129590 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 765633 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention