BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 13261560 · Received January 14, 2022

    Report

    Report Number
    3006630150-2021-07610
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    December 7, 2021
    Report Date
    January 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, APPROXIMATED BASED ON THE APPOINTMENT DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7083280/7083373.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING AT THE IPG AND LEAD SITES. IT WAS NOTED THAT THE PHYSICIAN DRAINED SOME FLUID FROM THE INCISION SITE WHEN THE PATIENT WAS IN FOR A STEROID INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729539 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 202943 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention