BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17775325 · Received September 19, 2023

    Report

    Report Number
    3006630150-2023-05673
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(6), BATCH: 7100767. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7072282. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8416500, MODEL: SC-8416-50, SERIAL: (B)(6), BATCH: 7075843.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED STAPHYLOCOCCUS EPIDERMIDIS INFECTION. THE LOCATION OF THE INFECTION WAS AT THE INCISION SITE. SYMPTOMS INCLUDE NAUSEA, VOMITING, PAIN, AND DRAINAGE. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE PATIENT WAS GIVEN ANTIBIOTICS. THE EXPLANTED PRODUCTS WERE DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594742 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 579683 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention