BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 13742219 · Received March 12, 2022

    Report

    Report Number
    3006630150-2022-00984
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    March 16, 2021
    Report Date
    June 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7073111/7075232.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING WORSENED PAIN AND WAS NOT GETTING AN ADEQUATE STIMULATION DESPITE REPROGRAMMING DONE. IT WAS MENTIONED THAT THE PATIENT HAD A BROKEN SCREW IN THE BACK FROM THE LAST SURGERY AND WAS SUSPECTED TO BE THE REASON OF WORSENED PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING WORSENED PAIN AND WAS NOT GETTING AN ADEQUATE STIMULATION DESPITE REPROGRAMMING DONE. IT WAS MENTIONED THAT THE PATIENT HAD A BROKEN SCREW IN THE BACK FROM THE LAST SURGERY AND WAS SUSPECTED TO BE THE REASON OF WORSENED PAIN. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LINEAR LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164656 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 502062 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention