BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18016670 · Received October 26, 2023

    Report

    Report Number
    3006630150-2023-06575
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    March 31, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7071211; PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7071203.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED ACUTE PAIN DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) MOVING POSITION AND BECOMING SUPERFICIAL AT THE IMPLANT SITE. ADDITIONALLY, THE PATIENT EXPERIENCED INADEQUATE STIMULATION AS HER PAIN PATTERN HAS CHANGED WHICH RESULTED IN THE SCS DEVICE NOT BEING AS EFFECTIVE. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE IPG AND LEADS WERE REMOVED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151122 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 539986 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention