BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 25194146 · Received May 15, 2026

    Report

    Report Number
    3006630150-2026-03196
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    January 17, 2026
    Report Date
    May 15, 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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7159292 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7163026 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN, SWELLING AND DRAINAGE AROUND THEIR SPINAL CORD STIMULATOR (SCS) IMPLANT SITE. IT WAS DISCOVERED THAT THE PATIENT WAS EXPERIENCING WOUND DEHISCENCE ON THEIR VERTICAL INCISION SITE. THE PATIENT WAS ALSO EXPERIENCING INEFFICIENT PAIN THERAPY AND FEVER. THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR CULTURE PRIOR TO PLACING THEM IN ANTIBIOTICS, CULTURE RESULTS WERE NOT PROVIDED. THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307189 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 792099 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention