BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 21341087 · Received February 9, 2025

    Report

    Report Number
    3006630150-2025-00581
    Event Type
    Injury
    Date Received
    February 9, 2025
    Date of Event
    August 9, 2024
    Report Date
    February 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A COUPLE OF MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH: 7093966/7093978.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE BATTERY SITE DESPITE REPROGRAMMING. DATABASE ANALYSIS REVEALED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) TEMPERATURE WAS WITHIN NORMAL RANGE WHEN IT WAS CHARGED AND THE PROVIDED IMPEDANCES WERE WITHIN RANGE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638386 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 588673 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention