BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16673980 · Received April 4, 2023

    Report

    Report Number
    3006630150-2023-01770
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    September 13, 2022
    Report Date
    April 4, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED SIX MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(4). BATCH: 5084678/5091579. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7099658/7099659.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IPG WAS UNCOMFORTABLE FOR THE PATIENT. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365147 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 525272 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention