BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 15910244 · Received December 2, 2022

    Report

    Report Number
    3006630150-2022-06711
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    November 2, 2022
    Report Date
    December 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7112926/7112991.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DESPITE REPROGRAMMING ATTEMPT. THE PATIENT RETURNED TO THE EMERGENCY ROOM AND WAS FOUND OUT THAT THERE WAS AN INFECTION AT THE IPG SITE. SYMPTOM OF PAIN WAS NOTED. THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED. IT WAS UNKNOWN IF ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946191 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 550108 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention