BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 14756974 · Received June 21, 2022

    Report

    Report Number
    3006630150-2022-03031
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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)(4); BATCH: 7070370/ 7070364/ 7075436.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOM OF DRAINAGE WAS NOTED, AND IT WAS UNKNOWN IF PATIENT WAS PLACED ON ANTIBIOTICS. THE PHYSICIAN BELIEVED THAT THE CAUSE OF INFECTION WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612842 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 531110 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention