BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24094529 · Received January 16, 2026

    Report

    Report Number
    3006630150-2026-00368
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    January 1, 2026
    Report Date
    May 4, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500 . MODEL: SC-2218-50 . SERIAL: (B)(6). BATCH: 7163702 / 7165064. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180 . MODEL: SC-4318 . BATCH: 36655650. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT DUE TO DRAINAGE AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. NO DEVICE MALFUNCTION WAS SUSPECTED. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT DUE TO DRAINAGE AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425224 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 802541 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization| R