BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 25333509 · Received May 29, 2026

    Report

    Report Number
    3006630150-2026-03615
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 2, 2026
    Report Date
    May 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EVENT DATE APPROXIMATED BASED ON PATIENT HOSPITAL ADMISSION DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2408-74. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7079007. MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 74 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2408-74. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080925. MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 74 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE WITH INCISION DRAINAGE DUE TO SUSPECTED INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD IMPLANT SITES. THE PATIENT PRESENTED WITH PAIN, SWELLING, AND HEADACHE, AND WAS HOSPITALIZED PRIOR TO SURGERY. CULTURES WERE OBTAINED DURING THE PROCEDURE, BUT RESULTS REMAIN UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS, AND THE DEVICES WERE RETAINED BY THE FACILITY FOR CULTURE TESTING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57749 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 820357 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1