BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 21321140 · Received February 6, 2025

    Report

    Report Number
    3006630150-2025-00463
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 6, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700 . MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7103022/7103106. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 35211201.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED OF HAVING AN INFECTION AROUND THE POCKET SITE, ACCOMPANIED BY BRUISING. THE PHYSICIAN DID NOT BELIEVE THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918854 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 764875 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention