BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 20761232 · Received November 22, 2024

    Report

    Report Number
    3006630150-2024-08062
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6). BATCH: 7081278/7081046.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION IN THE STOMACH AND WAS NOT RECEIVING RELIEF FROM SPINAL CORD STIMULATION (SCS) DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT A REVISION PROCEDURE, WHEREIN THE CURRENTLY IMPLANTED SPINAL CORD STIMULATION (SCS) LEADS WERE MOVED DOWN. THE PHYSICIAN OPTED TO REPLACE THE IMPLANTABLE PULSE GENERATOR (IPG) IN CASE THE ISSUE WAS RELATED TO THE BATTERY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404138 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 578906 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1