BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23330943 · Received October 17, 2025

    Report

    Report Number
    3006630150-2025-09238
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    July 2, 2024
    Report Date
    January 16, 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 COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION? CX UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 7080646 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION? CX. UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7080646, UDI: ((B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED A LOSS OF THERAPY AND PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE OF THE IPG AND LEADS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY OF THE REVISION PROCEDURE. THE OUTCOME OF THE EVENT IS NOTED TO HAVE RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THE CLINICAL STUDY PATIENT EXPERIENCED A LOSS OF THERAPY AND PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE OF THE IPG AND LEADS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY OF THE REVISION PROCEDURE. THE OUTCOME OF THE EVENT IS NOTED TO HAVE RESOLVED. THE LEAD WAS DISCARDED. NO FURTHER INFORMATION REGARDING THE LOCATION OF THE EXPLANTED IPG HAS BEEN ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONALLY, THE REVISION PROCEDURE, WAS ALSO BECAUSE THE PATIENT EXPERIENCED DISCOMFORT DUE TO MECHANICAL PROTRUSION AND CLICKING SENSATIONS AT MIDLINE SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379418 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 500616 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention