BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22671799 · Received July 30, 2025

    Report

    Report Number
    3006630150-2025-05995
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR? 3-4 UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7078514. BRAND NAME: LINEAR? 3-4 UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7080550.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUSPECTED INFECTION AT THE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) SITE. OBSERVABLE WOUND OPENING, FLUID DISCHARGE, AND ODOR WERE PRESENT AT THE IPG WOUND SITE. THE WOUND WAS SWABBED, AND WHILE IT REMAINS UNKNOWN WHETHER ANTIBIOTICS WERE ADMINISTERED, THE SYSTEM WAS SUBSEQUENTLY EXPLANTED ONCE THE INFECTION WAS CONFIRMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERED POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514327 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 788075 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization| R