BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 23501175 · Received November 7, 2025

    Report

    Report Number
    3006630150-2025-10137
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    March 19, 2025
    Report Date
    March 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: 7080366. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: 7073554. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 27370035. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 33308881. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE IPG AND LEADS WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: 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, 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 OVER TIME, THE STIMULATOR MAY MOVE FROM ITS ORIGINAL POSITION ARE A KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, 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. BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE AND UNABLE TO EXCLUDE DEVICE PROBLEM WILL BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PATIENT TURNS THE STIMULATOR OFF AND LAYS IN A CERTAIN POSITION, THE PATIENT IMMEDIATELY GETS AN INTENSE SHOCKING STIMULATION. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENTS BACK WAS OBSERVED WITH A VISIBLE BUMP OVER MIDLINE INCISION AND MODERATE MOBILITY OF IMPLANTABLE PULSE GENERATOR (IPG) IN THE POCKET. THE PATIENT HAD A REVISION PROCEDURE THAT DID NOT RESOLVE THE ISSUE AND THEN UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PATIENT TURNS THE STIMULATOR OFF AND LAYS IN A CERTAIN POSITION, THE PATIENT IMMEDIATELY GETS AN INTENSE SHOCKING STIMULATION. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT'S BACK WAS OBSERVED WITH A VISIBLE BUMP OVER MIDLINE INCISION AND MODERATE MOBILITY OF IMPLANTABLE PULSE GENERATOR (IPG) IN THE POCKET. THE PATIENT HAD A REVISION PROCEDURE THAT DID NOT RESOLVE THE ISSUE AND THEN UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PATIENT TURNS THE STIMULATOR OFF AND LAYS IN A CERTAIN POSITION, THE PATIENT IMMEDIATELY GETS AN INTENSE SHOCKING STIMULATION. IT WAS ALSO NOTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENTS BACK WAS OBSERVED WITH A VISIBLE BUMP OVER MIDLINE INCISION AND MODERATE MOBILITY OF IMPLANTABLE PULSE GENERATOR (IPG) IN THE POCKET. THE PATIENT HAD A REVISION PROCEDURE THAT DID NOT RESOLVE THE ISSUE AND THEN UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259529 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 225492 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention