BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 12091704 · Received June 30, 2021

    Report

    Report Number
    3006630150-2021-03337
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7071687/7072810.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. FLUID DISCHARGES WERE THE ONLY SYMPTOM NOTED. IT WAS UNKNOWN WHETHER INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992227 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 202724 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention