BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 16791552 · Received April 21, 2023

    Report

    Report Number
    3006630150-2023-02195
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    February 28, 2023
    Report Date
    April 21, 2023
    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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED PAST TWO WEEKS FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4)/(B)(4), BATCH: 5130281/5152342.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THE PATIENT WAS EXPERIENCING SORENESS AND SOME SWELLING WITH A POSSIBLE CYST THAT IS NOT DEVICE RELATED IN PATIENTS LOWER BACK. IT WAS ALSO REPORTED THAT THE PATIENTS CYST WAS OPENED. THE PHYSICIAN LANCED THE CYST AREA AND INSERTED A DRAIN AND PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792175 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 351506 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention