BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23432744 · Received October 30, 2025

    Report

    Report Number
    3006630150-2025-09836
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    August 25, 2025
    Report Date
    December 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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:7070994, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-CHARGERS. UPN: M365SC641230. MODEL: SC-6412-3. SERIAL: (B)(6). BATCH: 392140. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE THAT SPREAD TO THE PADDLE LEAD. SYMPTOMS OF FEVER, CHILLS, HEADACHE, BURNING SENSATION AND PAIN AT THE IPG SITE WERE NOTED. THE PHYSICIAN BELIEVED THAT OVERHEATING OF THE IPG WAS WHAT CAUSED THE INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS, HOWEVER, THE SYMPTOMS WORSENED. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE THAT SPREAD TO THE PADDLE LEAD. SYMPTOMS OF FEVER, CHILLS, HEADACHE AND PAIN AT THE IPG SITE WERE NOTED. THE PHYSICIAN BELIEVED THAT OVERHEATING OF THE IPG WAS WHAT CAUSED THE INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS, HOWEVER, THE SYMPTOMS WORSENED. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED SHOCKING STIMULATION THAT CAUSED A LOT OF PAIN. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN CHARGING THE IPG USING THE OLD CHARGER. THE SAID CHARGER OVERHEATED AND CAUSED BURNS, WHICH IN TURN, HAD LED TO THINNING OF THE SKIN AND INFECTION. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS FOLLOWING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55627 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 790370 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| H