BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 11645625 · Received April 9, 2021

    Report

    Report Number
    3006630150-2021-01486
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 21, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS: UPN: M365SC8336700, MODEL: SC-8336-70, SERIAL: (B)(4), BATCH: 7070785. APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. IT WAS NOTED THAT THE CAUSE OF INFECTION WAS UNKNOWN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS PLACED WITH LINEZORID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540416 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 504710 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention