BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 22167291 · Received June 9, 2025

    Report

    Report Number
    3006630150-2025-04075
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    April 19, 2025
    Report Date
    June 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7072884. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY WALKING AS A RESULT OF OVERSTIMULATION. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS OBTAINED STATING THAT THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY WALKING AS A RESULT OF OVERSTIMULATION. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477934 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 214546 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention