BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22475499 · Received July 10, 2025

    Report

    Report Number
    3006630150-2025-05382
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 2, 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: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7082338, UDI: (B)(4). BRAND NAME: LINEAR 3-4, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7082815, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-4 UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7082338, UDI: (B)(4). BRAND NAME: LINEAR 3-4 UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7082815, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE LEAD INSERTION SITE AND IMPLANTABLE PULSE GENERATOR (IPG) SITE, OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE PATIENT PRESENTED TO THE HOSPITAL WITH REDNESS AND SORENESS AT THE INFECTION SITES. IT IS SUSPECTED THAT THE INFECTION MAY BE PROCEDURE RELATED OR INCIDENTAL POST IMPLANTATION. THE PATIENT WAS HOSPITALIZED, GIVEN INTRAVENOUS (IV) ANTIBIOTICS, AND UNDERWENT A SYSTEM EXPLANT. CULTURES WERE TAKEN, HOWEVER THE RESULTS ARE UNKNOWN. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE LEAD INSERTION SITE AND IMPLANTABLE PULSE GENERATOR (IPG) SITE, OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE PATIENT PRESENTED TO THE HOSPITAL WITH REDNESS AND SORENESS AT THE INFECTION SITES. IT IS SUSPECTED THAT THE INFECTION MAY BE PROCEDURE RELATED OR INCIDENTAL POST IMPLANTATION. THE PATIENT WAS HOSPITALIZED, GIVEN INTRAVENOUS (IV) ANTIBIOTICS, AND UNDERWENT A SYSTEM EXPLANT. THE PATIENT IS DOING WELL POST OPERATIVELY AND HAS BEEN DISCHARGED FROM THE HOSPITAL. CULTURES WERE TAKEN, HOWEVER THE RESULTS ARE UNKNOWN. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820606 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 784852 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention| H