BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22000522 · Received May 12, 2025

    Report

    Report Number
    3006630150-2025-03260
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    May 4, 2022
    Report Date
    June 13, 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
    NH, 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-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(6), BATCH: 7072702, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(6), BATCH: 7073499, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF, JOLTING SENSATION AND DISCOMFORT IN THE RIGHT PALM OF THE HAND WITH FLEXION OF THE NECK. PROGRAM OPTIMIZATION WAS ATTEMPTED AND WAS NOT SUCCESSFUL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF, JOLTING SENSATION AND DISCOMFORT IN THE RIGHT PALM OF THE HAND WITH FLEXION OF THE NECK. PROGRAM OPTIMIZATION WAS ATTEMPTED AND WAS NOT SUCCESSFUL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370914 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 522271 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention