BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11579629 · Received March 27, 2021

    Report

    Report Number
    3006630150-2021-01250
    Event Type
    Injury
    Date Received
    March 27, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(6), MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7072181.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING FEELING AFTER FIVE MINUTES OF CHARGING WHICH THE PATIENT COULD NOT HANDLE. IT WAS MENTIONED THAT THE PATIENT WAS VETTED BECAUSE OF ALLERGIES HOWEVER THE PHYSICIAN BELIEVED THAT THIS WAS NOT DEVICE RELATED BUT DUE TO THE SENSITIVITY ON THE OUTSIDE OF THE PATIENTS SKIN. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475894 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 366210 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention