BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11919218 · Received June 2, 2021

    Report

    Report Number
    3006630150-2021-02593
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 10, 2021
    Report Date
    November 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED IPG WILL NOT BE RETURNED TO BSC AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INFECTION SYMPTOMS AT THE IPG AND LEAD SITES. THE PATIENT WAS PLACED ON ANTIBIOTICS BUT WAS STILL EXPERIENCING PAIN, REDNESS, SWELLING AND DISCHARGE IN THOSE AREAS 5 DAYS LATER AS WELL AS A FEVER. THE PATIENT ENDED UP BEING HOSPITALIZED AND BEING PLACED ON IV ANTIBIOTICS WHILE UNDER SUPERVISION. THE PATIENT'S 2 LINEAR LEADS WERE EXPLANTED AS INFECTION WAS EVIDENT AT BOTH LEAD SITES. THE WOUND SITES WERE WASHED OUT AS WELL. THE IPG REMAINS IMPLANTED AS IT APPEARED TO BE CLEAR OF INFECTION. THE CAUSE OF THE INFECTION IS NOT KNOWN. THE PATIENT WILL STAY ADMITTED IN THE HOSPITAL FOR AN ADDITIONAL WEEK UNDER PHYSICIAN'S CARE FOLLOWING THE EXPLANT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS EXPERIENCING ONGOING SYMPTOMS AND TAKING ANTIBIOTICS THE ENTIRE TIME WHILE BEING IMPLANTED. THE PATIENT HAS FULLY RECOVERED FOLLOWING THE EXPLANT SURGERY.

    Additional Manufacturer Narrative · 1

    THE IPG WILL NOT BE RETURNED TO BSC AS IT REMAINS IMPLANTED. THE EXPLANTED LINEAR LEADS WILL NOT BE RETURNED TO BSC AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7071999. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7071870.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INFECTION SYMPTOMS AT THE IPG AND LEAD SITES. THE PATIENT WAS PLACED ON ANTIBIOTICS BUT WAS STILL EXPERIENCING PAIN, REDNESS, SWELLING AND DISCHARGE IN THOSE AREAS 5 DAYS LATER AS WELL AS A FEVER. THE PATIENT ENDED UP BEING HOSPITALIZED AND BEING PLACED ON IV ANTIBIOTICS WHILE UNDER SUPERVISION. THE PATIENT'S 2 LINEAR LEADS WERE EXPLANTED AS INFECTION WAS EVIDENT AT BOTH LEAD SITES. THE WOUND SITES WERE WASHED OUT AS WELL. THE IPG REMAINS IMPLANTED AS IT APPEARED TO BE CLEAR OF INFECTION. THE CAUSE OF THE INFECTION IS NOT KNOWN. THE PATIENT WILL STAY ADMITTED IN THE HOSPITAL FOR AN ADDITIONAL WEEK UNDER PHYSICIAN'S CARE FOLLOWING THE EXPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818010 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 356316 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R