BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24193165 · Received January 27, 2026

    Report

    Report Number
    3006630150-2026-00543
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    January 1, 2023
    Report Date
    April 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    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 THE MEDICAL FACILITY DOES NOT RELEASE CONTAMINATED PRODUCTS. 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 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). 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). BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED TWO YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6) BATCH: 17767536 UDI: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500 MODEL: SC-8216-50 SERIAL: (B)(6) BATCH: 19335541 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6) BATCH: 18258346 UDI: (B)(4). PRODUCT FAMILY: LINEAR 3-6 LEAD 50 CM UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6) BATCH: 7071860 UDI: (B)(4). PRODUCT FAMILY: LINEAR 3-6 LEAD 50 CM UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6) BATCH: 7071863 UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS UPN: M365SC3354250 MODEL: SC-3354-25 SERIAL: (B)(6) BATCH: 7070023 UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS UPN: M365SC3354250 MODEL: SC-3354-25 SERIAL: (B)(6) BATCH: 7070021 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH: 17382293 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH: 17382293 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE FOLLOW-UP 1 MDR IN BLOCK H2. CORRECTION TO THE FOLLOW-UP 1 MDR IN BLOCK H11. THE EXPLANTED DEVICES HAVE NOT BEEN RETURNED AS THE MEDICAL FACILITY DOES NOT RELEASE CONTAMINATED PRODUCTS. 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 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). BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED TWO YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 17767536, UDI: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6). BATCH: 19335541, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 18258346, UDI: (B)(4). PRODUCT FAMILY: LINEAR 3-6 LEAD 50 CM, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7071860, UDI: (B)(4). PRODUCT FAMILY: LINEAR 3-6 LEAD 50 CM, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7071863, UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3354250, MODEL: SC-3354-25, SERIAL: (B)(6), BATCH: 7070023, UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3354250, MODEL: SC-3354-25, SERIAL: (B)(6), BATCH: 7070021, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 17382293, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 17382293, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED TWO YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 17767536 UDI: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500 MODEL: SC-8216-50 SERIAL: (B)(6). BATCH: 19335541 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 18258346 UDI: (B)(4). PRODUCT FAMILY: LINEAR 3-6 LEAD 50 CM UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 7071860 UDI: (B)(4). PRODUCT FAMILY: LINEAR 3-6 LEAD 50 CM UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 7071863 UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS UPN: M365SC3354250 MODEL: SC-3354-25 SERIAL: (B)(6). BATCH: 7070023 UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS UPN: M365SC3354250 MODEL: SC-3354-25 SERIAL: (B)(6). BATCH: 7070021 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6). BATCH: 17382293 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6). BATCH: 17382293 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE FOLLOW-UP 1 MDR IN BLOCK H11. THE EXPLANTED DEVICES HAVE NOT BEEN RETURNED AS THE MEDICAL FACILITY DOES NOT RELEASE CONTAMINATED PRODUCTS. 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 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). BLOCK B3: EXACT DATE UNKNOWN, EVENT LIKELY OCCURRED TWO YEARS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 17767536, UDI: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 19335541, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 18258346, UDI: (B)(4). PRODUCT FAMILY: LINEAR 3-6 LEAD 50 CM, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7071860, UDI: (B)(4). PRODUCT FAMILY: LINEAR 3-6 LEAD 50 CM, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7071863, UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3354250, MODEL: SC-3354-25, SERIAL: (B)(6), BATCH: 7070023, UDI: (B)(4). PRODUCT FAMILY: SCS-SPLITTERS, UPN: M365SC3354250, MODEL: SC-3354-25, SERIAL: (B)(6), BATCH: 7070021, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 17382293, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 17382293, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION RESULTING IN LACK OF PAIN RELIEF. THE PATIENT HAD NO RECENT HISTORY OF TRAUMA, WEIGHT CHANGE, IPG ROTATION WITHIN THE POCKET, OR LEAD MIGRATION. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. POSTOPERATIVELY, THE PATIENT IS RECOVERING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED, AS THE MEDICAL FACILITY DOES NOT RELEASE CONTAMINATED PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION RESULTING IN LACK OF PAIN RELIEF. THE PATIENT HAD NO RECENT HISTORY OF TRAUMA, WEIGHT CHANGE, IPG ROTATION WITHIN THE POCKET, OR LEAD MIGRATION. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. POSTOPERATIVELY, THE PATIENT IS RECOVERING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED, AS THE MEDICAL FACILITY DOES NOT RELEASE CONTAMINATED PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION RESULTING IN LACK OF PAIN RELIEF. THE PATIENT HAD NO RECENT HISTORY OF TRAUMA, WEIGHT CHANGE, IPG ROTATION WITHIN THE POCKET, OR LEAD MIGRATION. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. POSTOPERATIVELY, THE PATIENT IS RECOVERING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED, AS THE MEDICAL FACILITY DOES NOT RELEASE CONTAMINATED PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION RESULTING IN LACK OF PAIN RELIEF. THE PATIENT HAD NO RECENT HISTORY OF TRAUMA, WEIGHT CHANGE, IPG ROTATION WITHIN THE POCKET, OR LEAD MIGRATION. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. POSTOPERATIVELY, THE PATIENT IS RECOVERING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED, AS THE MEDICAL FACILITY DOES NOT RELEASE CONTAMINATED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84407 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 372418 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1