BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21032607 · Received December 29, 2024

    Report

    Report Number
    3006630150-2024-09134
    Event Type
    Injury
    Date Received
    December 29, 2024
    Date of Event
    October 17, 2024
    Report Date
    December 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7141005/7138845.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THAT PATIENT HAD EXPERIENCE DISCOMFORT AND PAIN AROUND THE IMPLANT SITE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS BEING THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744952 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 755059 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention