BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 23919253 · Received December 29, 2025

    Report

    Report Number
    3006630150-2025-11761
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    September 18, 2023
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7130477. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7130002. 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: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7130477 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7130002 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE SC-1216 SERIAL NUMBER (B)(6) WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. HOWEVER, A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES: SYSTEM FAILURE, WHICH CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURE(S) OF THE COMPONENTS OR THE BATTERY. THESE EVENTS, WHICH MAY INCLUDE DEVICE FAILURE, LEAD BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, CAN RESULT IN INEFFECTIVE PAIN CONTROL AND 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 ARE A KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: KNOWN INHERENT RISK OF DEVICE. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7130477, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7130002, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM WAS REMOVED FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED AT THIS TIME. ADDITIONAL INFORMATION INDICATED THAT THE SCS PATIENT EXPERIENCED INADEQUATE STIMULATION, CAUSING UNSATISFACTORY PAIN CONTROL. TO ADDRESS THIS, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND BOTH LEADS WERE REMOVED AND REPLACED. THE PATIENT IS REPORTED TO BE RECOVERING WELL POSTOPERATIVELY. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICES WERE DISPOSED OF AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM WAS REMOVED FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM WAS REMOVED FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED AT THIS TIME. ADDITIONAL INFORMATION INDICATED THAT THE SCS PATIENT EXPERIENCED INADEQUATE STIMULATION, CAUSING UNSATISFACTORY PAIN CONTROL. TO ADDRESS THIS, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND BOTH LEADS WERE REMOVED AND REPLACED. THE PATIENT IS REPORTED TO BE RECOVERING WELL POSTOPERATIVELY. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICES WERE DISPOSED OF AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402529 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 580627 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention