BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21032178 · Received December 29, 2024

    Report

    Report Number
    3006630150-2024-09118
    Event Type
    Injury
    Date Received
    December 29, 2024
    Date of Event
    March 10, 2023
    Report Date
    December 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7120775/7121432.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION AND PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. IT WAS ALSO NOTED THAT THE LEADS MIGRATED AND WHEN STIMULATION WAS ON, IT WORSENS THE NERVE PAIN AT TIMES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812678 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 563000 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention