BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 15379022 · Received September 8, 2022

    Report

    Report Number
    3006630150-2022-04623
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    July 13, 2022
    Report Date
    November 11, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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)(4). BATCH: 7073397 / 7080958.

    Additional Manufacturer Narrative · 0

    SC-1216 SN: ((B)(6)). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2218-70 SN: ((B)(6)). THE RETURNED LEAD WAS ANALYZED AND REVEALED THAT IT WAS SEVERED INTO TWO PIECES APPROXIMATELY 44 CM FROM THE DISTAL END. NO ANOMALIES WERE OBSERVED ON THE LEAD ASIDE FROM THIS DAMAGE. THE DAMAGE TO THE LEAD WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AROUND THE PATIENTS IPG AND LEAD SITE WERE SWOLLEN AND THAT THE PATIENT HAD A LOT OF ALLERGIES. THE PATIENT WAS EXPERIENCING DISCOMFORT FROM THE SWELLING AND WAS NOT GETTING ADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG AND LEAD EXPLANT PROCEDURE. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AROUND THE PATIENTS IPG AND LEAD SITE WERE SWOLLEN AND THAT THE PATIENT HAD A LOT OF ALLERGIES. THE PATIENT WAS EXPERIENCING DISCOMFORT FROM THE SWELLING AND WAS NOT GETTING ADEQUATE STIMULATION. THE PATIENT UNDERWENT AN IPG AND LEAD EXPLANT PROCEDURE. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261870 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 527997 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention