BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24063350 · Received January 13, 2026

    Report

    Report Number
    3006630150-2026-00317
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 16, 2025
    Report Date
    April 15, 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
    NY, 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. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6) BATCH: 5131409. UDI: (B)(4) PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6) BATCH: 5131689. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5131409. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5131689. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE SC-1160 SERIAL NUMBER (B)(6) WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT 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 ARE KNOWN RISKS WITH THE USE OF SPINAL CORD STIMULATION (SCS). BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: KNOWN INHERENT RISK OF DEVICE. THE DEVICES SC-2317-50 SERIAL NUMBER (B)(6) WERE NOT RETURNED FOR ANALYSIS AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: CAUSE NOT ESTABLISHED. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50 SERIAL: (B)(6) BATCH: 5131409, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5131689, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE STIMULATION, AND HIGH IMPEDANCES WERE IDENTIFIED ON LEADS. TO ADDRESS THIS, THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND BOTH LEADS WERE REMOVED AND REPLACED. THE PATIENT WAS REPORTED WELL POSTOPERATIVELY. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICES WERE DISCARDED AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE STIMULATION, AND HIGH IMPEDANCES WERE IDENTIFIED ON LEADS. TO ADDRESS THIS, THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND BOTH LEADS WERE REMOVED AND REPLACED. THE PATIENT WAS REPORTED WELL POSTOPERATIVELY. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICES WERE DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163376 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 370577 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1