BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23019090 · Received September 10, 2025

    Report

    Report Number
    3006630150-2025-07430
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 13, 2025
    Report Date
    January 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION CX UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 7080160 UDI: (B)(4). BRAND NAME: INFINION CX UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 7080159 UDI: (B)(4). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE RETURNED LEAD SC-2317-70 SN (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE RETURNED LEAD SC-2317-70 SN (B)(6) WAS ANALYZED AND FOUND THAT THE LEAD BODY WAS PARTIALLY SLICED; HOWEVER, THE INTERNAL CABLES WERE NOT COMPROMISED. THE DAMAGE LIKELY OCCURRED DURING THE EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE LEAD. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU), PRODUCT LABEL. ADDITIONALLY, LABELING STATES THAT 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. ALL OF WHICH ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. TECHNICIANS CONFIRMED THROUGH TECHNICAL ANALYSIS THAT THE DEVICES PASSED THE TESTS PERFORMED AND EXHIBITED NORMAL CHARACTERISTICS, OTHER THAN THE REMOVAL DAMAGE TO THE ONE LEAD. THE CAUSE OF ITCHING WAS UNABLE TO BE DETERMINED. HOWEVER, BASED ON THE REPORTED OBSERVATIONS AND A REVIEW OF THE PRODUCT LABELING, IT HAS BEEN CONCLUDED THAT ITCHING, IS A KNOWN INHERENT RISK ASSOCIATED WITH USE OF THE DEVICES, AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION? CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). BRAND NAME: INFINION? CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION? CX, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7080160, UDI: (B)(4). BRAND NAME: INFINION? CX, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7080159, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTREME BODY-WIDE ITCHING WHEN THE SPINAL CORD STIMULATION (SCS) WAS TURNED ON AND MIXED RESULTS WHEN IT WAS OFF. THEREFORE, FOR PEACE OF MIND, THE PATIENT REQUESTED AND UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE CAUSE OF THE ITCHING IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY; HOWEVER, THE ITCHING HAD NOT RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTREME BODY-WIDE ITCHING WHEN THE SPINAL CORD STIMULATION (SCS) WAS TURNED ON AND MIXED RESULTS WHEN IT WAS OFF. THEREFORE, FOR PEACE OF MIND, THE PATIENT REQUESTED AND UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE CAUSE OF THE ITCHING IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTREME BODY-WIDE ITCHING WHEN THE SPINAL CORD STIMULATION (SCS) WAS TURNED ON AND MIXED RESULTS WHEN IT WAS OFF. THEREFORE, FOR PEACE OF MIND, THE PATIENT REQUESTED AND UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE CAUSE OF THE ITCHING IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY; HOWEVER, THE ITCHING HAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778337 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 553455 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention