BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17326717 · Received July 14, 2023

    Report

    Report Number
    3006630150-2023-04135
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7089852/7090354.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. SYMPTOMS OF PAIN AND SUPERFICIAL DEHISCENCE WERE NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT HAD BEEN ON THREE ROUNDS OF ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICE COMPONENTS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207854 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 560691 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention