BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9339223 · Received November 18, 2019

    Report

    Report Number
    3006630150-2019-06618
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 21, 2019
    Report Date
    January 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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: 5073303/5000566.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS IPG CONTINUES TO PROTRUDE OUT AND WAS CAUSING WORSENING PAIN. IT WAS UNKNOWN IF THERE WAS A SKIN BREAKAGE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE AND UNWANTED STIMULATION IN NONTARGET AREAS CAUSING IRRITATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG CONTINUES TO PROTRUDE OUT AND WAS CAUSING WORSENING PAIN. IT WAS UNKNOWN IF THERE WAS A SKIN BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129256 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 337400 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention