BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME 16

    MDR report key: 24283304 · Received February 6, 2026

    Report

    Report Number
    3006630150-2026-00764
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    August 1, 2025
    Report Date
    May 18, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SINCE IMPLANT PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. CORRECTION TO THE INITIAL MDR IN BLOCK H11. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS UPN: M365SC9218150 MODEL: SC-9218-15 SERIAL: (B)(6) BATCH: 7081805 UDI: (B)(4). PRODUCT FAMILY: SCS-ADAPTERS UPN: M365SC9218150 MODEL: SC-9218-15 SERIAL: (B)(6) BATCH: 7081763 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SINCE IMPLANT PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS LOSING CONNECTION WITH THE PATIENTS TRANSMITTER. PATIENT WAS ALSO EXPERIENCING HEAT, WARMTH AND IRRITATION AT THE BATTERY SITE. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE. THE PATIENT IS DOING WELL POSTOPERATIVELY. OLD PRODUCT WAS DISPOSED OF AT THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS LOSING CONNECTION WITH THE PATIENTS TRANSMITTER. PATIENT WAS ALSO EXPERIENCING HEAT, WARMTH AND IRRITATION AT THE BATTERY SITE. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE. THE PATIENT IS DOING WELL POSTOPERATIVELY. OLD PRODUCT WAS DISPOSED OF AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533065 WAVEWRITER ALPHA? PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 239547 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1