BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15245256 · Received August 17, 2022

    Report

    Report Number
    3006630150-2022-04128
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 16, 2022
    Report Date
    August 17, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(4); BATCH: 3163113/7071152.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. SYMPTOMS OF PAIN AND REDNESS WAS NOTED. THE PHYSICIAN BELIEVE IT WAS NOT DEVICE RELATED AND IT WAS A LOW GRADE INFECTION THAT GOT WORSE. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245034 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 512652 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention