BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 21655701 · Received March 20, 2025

    Report

    Report Number
    3006630150-2025-01665
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    July 1, 2024
    Report Date
    March 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED APPROXIMATELY ONE MONTH AGO PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7142791/7142959.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE COVERAGE OF PAIN AREAS. UNDESIRED RIB STIMULATION WAS ALSO NOTED. X-RAY CONFIRM THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD MIGRATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451739 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 753465 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention