BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16752263 · Received April 17, 2023

    Report

    Report Number
    3006630150-2023-02055
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: 7081164/7081172.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SUPERFICIAL INFECTION AT THE POCKET AND MIDLINE INCISION SITE. SYMPTOMS OF FEVER, ABSCESS AND YELLOWISH DRAINAGE WERE NOTED, AS WELL AS PAIN AND DISCOMFORT IN THE POCKET SITE. THE PATIENT WAS PRESCRIBED WITH INTRAVENOUS ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DEVICE RELATED. ALL EXPLANTED DEVICES WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827419 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 556608 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention