BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24945273 · Received April 21, 2026

    Report

    Report Number
    3006630150-2026-02514
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2318-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5006020, MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2318-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5002137, MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318, SERIAL NUMBER: NA, BATCH/LOT NUMBER: 37920470, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET AND MIDLINE INCISION SITES. SYMPTOMS OF FEVER, PAIN AND OOZING INCISIONS WERE NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND EXPECTED TO FULLY RECOVER. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204620 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 809181 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1