BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15538270 · Received October 4, 2022

    Report

    Report Number
    3006630150-2022-05257
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    September 12, 2022
    Report Date
    August 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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)(4); BATCH: 7081985/7083473.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG POCKET SITE AND WAS HOSPITALIZED. SYMPTOMS OF PAIN AND INFLAMMATION WERE NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS GIVEN AN ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG POCKET SITE AND WAS HOSPITALIZED. SYMPTOMS OF PAIN AND INFLAMMATION WERE NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS GIVEN AN ANTIBIOTIC. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED IPG WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY. CULTURES WERE TAKEN AND THE RESULTS WERE NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG POCKET SITE AND WAS HOSPITALIZED. SYMPTOMS OF PAIN AND INFLAMMATION WERE NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS GIVEN AN ANTIBIOTIC. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED IPG WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY. CULTURES WERE TAKEN AND THE RESULTS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388031 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 545875 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| H