BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22783797 · Received August 12, 2025

    Report

    Report Number
    3006630150-2025-06403
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER A COUPLE WEEKS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7163456/7164412. UDI: (B)(4) / (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 36495274. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO CONCERN FOR INFECTION. REDNESS AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WAS NOTED. THE PHYSICIAN BELIEVED THAT IT WAS NOT DEVICE OR PROCEDURE RELATED. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419740 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 789601 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention