BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 16025474 · Received December 21, 2022

    Report

    Report Number
    3006630150-2022-07154
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    February 17, 2021
    Report Date
    December 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY FOUR MONTHS AFTER THE IMPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7073635/7073634; PRODUCT FAMILY: SCS-LEAD FIXATION-MRI, UPN: M365SC43190, MODEL: SC-4319, BATCH: 27053392.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. IT WAS NOTED THAT THE PATIENT EXPERIENCED MUSCLE SPASMS, UNDESIRED AND INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RELEASED BY THE HOSPITAL SO THEY WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612198 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 508829 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention