BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 16090453 · Received January 3, 2023

    Report

    Report Number
    3006630150-2022-07456
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7113802/7113850.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE AND AN OPENING AT THE IPG INCISION SITE. IT WAS BELIEVED THAT SYMPTOMS WERE NOT DEVICE RELATED AND THAT IT MIGHT BE DUE TO HOW THE PHYSICIAN CLOSED THE INCISION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PUT ON ANTIBIOTICS. ALL DEVICE COMPONENTS EXPLANTED WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146668 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 549388 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention