BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22008998 · Received May 13, 2025

    Report

    Report Number
    3006630150-2025-03302
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    January 7, 2025
    Report Date
    August 19, 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
    FL, 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: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7080883, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7081683, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT SIMILAR TO RESTLESS LEG SYNDROME WHEN STIMULATION WAS ON WHILE SITTING, DRIVING OR LYING DOWN. IT WAS ALSO STATED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING AND ISSUES CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT SIMILAR TO RESTLESS LEG SYNDROME WHEN STIMULATION WAS ON WHILE SITTING, DRIVING OR LYING DOWN. IT WAS ALSO STATED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING AND ISSUES CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241628 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 587604 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention