BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 16820370 · Received April 26, 2023

    Report

    Report Number
    3006630150-2023-02302
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    May 16, 2022
    Report Date
    April 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5173481/5173450. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5159714.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD IPG SITE PAIN DUE TO PATIENT'S BATTERY FLIPPING SIDE TO SIDE. IT WAS ALSO REPORTED THAT THE PATIENT WAS SAID TO BE EXPERIENCING INADEQUATE STIMULATION, FEELING AS THOUGH THE BATTERY MAY BE OVERSTIMULATING AND CAUSING NAUSEA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE SURGERY CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335650 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365186 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention