BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24318537 · Received February 11, 2026

    Report

    Report Number
    3006630150-2026-00843
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED DEVICES HAVE NOT BEEN RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, A LABELING REVIEW WAS CONDUCTED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AND STATES THAT OVER TIME, THE STIMULATOR MAY MOVE FROM ITS ORIGINAL POSITION, AND THE LEAD MIGRATION RESULTS IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF. UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE AND PERSISTENT PAIN AT THE IPG OR LEAD SITE, ALL OF WHICH ARE KNOWN RISKS ASSOCIATED WITH THE USE OF SPINAL CORD STIMULATION (SCS). A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. HOWEVER, A LABELLING REVIEW FOUND THAT THE REPORTED EVENT IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION (SCS). CORRECTION TO THE INITIAL MDR IN BLOCK: H6. BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED IN AT THE BEGINNING OF JANUARY WHEN PATIENT STATED TO THE PHYSICIAN, HE WAS DISCOMFORT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 32842728, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7082306, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7082361, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED IN AT THE BEGINNING OF JANUARY WHEN PATIENT STATED TO THE PHYSICIAN, HE WAS DISCOMFORT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 BATCH: 32842728 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500 MODEL: SC-2352-50 SERIAL: (B)(6). BATCH: 7082306 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500 MODEL: SC-2352-50 SERIAL: (B)(6). BATCH: 7082361 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT WAS EXPERIENCING DISCOMFORT AT BOTH THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND THE ANCHOR SITE. DURING EVALUATION, THE PHYSICIAN NOTED THAT THE IMPLANTED COMPONENTS APPEARED TO BE POSITIONED MORE SUPERFICIALLY. THE PATIENT HAD NOT EXPERIENCED ANY RECENT WEIGHT LOSS BUT HAD BECOME MORE PHYSICALLY ACTIVE. X RAY IMAGING DEMONSTRATED THAT THE RIGHT LEAD HAD MIGRATED INFERIORLY BY ONE VERTEBRAL LEVEL, RESULTING IN A REDUCTION IN THERAPY EFFECTIVENESS. THE PATIENT ALSO REPORTED EXPERIENCING SEVERAL RECENT FALLS, INCLUDING ONE SIGNIFICANT FALL; HOWEVER, THESE EVENTS WERE ASSESSED AS UNRELATED TO THE DEVICE. BASED ON THE CLINICAL FINDINGS, A REVISION PROCEDURE WAS PERFORMED IN WHICH ONLY THE LEADS AND ANCHOR WERE REPLACED AND THE IPG WAS REPOSITIONED. POSTOPERATIVELY, THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT WAS EXPERIENCING DISCOMFORT AT BOTH THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND THE ANCHOR SITE. DURING EVALUATION, THE PHYSICIAN NOTED THAT THE IMPLANTED COMPONENTS APPEARED TO BE POSITIONED MORE SUPERFICIALLY. THE PATIENT HAD NOT EXPERIENCED ANY RECENT WEIGHT LOSS BUT HAD BECOME MORE PHYSICALLY ACTIVE. X RAY IMAGING DEMONSTRATED THAT THE RIGHT LEAD HAD MIGRATED INFERIORLY BY ONE VERTEBRAL LEVEL, RESULTING IN A REDUCTION IN THERAPY EFFECTIVENESS. THE PATIENT ALSO REPORTED EXPERIENCING SEVERAL RECENT FALLS, INCLUDING ONE SIGNIFICANT FALL; HOWEVER, THESE EVENTS WERE ASSESSED AS UNRELATED TO THE DEVICE. BASED ON THE CLINICAL FINDINGS, A REVISION PROCEDURE WAS PERFORMED IN WHICH ONLY THE LEADS AND ANCHOR WERE REPLACED AND THE IPG WAS REPOSITIONED. POSTOPERATIVELY, THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100778 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 769128 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention