BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16585154 · Received March 21, 2023

    Report

    Report Number
    3006630150-2023-01435
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    August 1, 2022
    Report Date
    March 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED AROUND AUGUST. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7071505/5092458.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELT THAT THE IPG POCKET SITE WAS BOTHERSOME AND THE PATIENT HAD CHARGING ISSUES. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9207 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 515696 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention