BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 13184222 · Received January 6, 2022

    Report

    Report Number
    3006630150-2021-07498
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    August 17, 2021
    Report Date
    January 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED SEVERAL MONTHS AGO FROM DATE MANUFACTURER WAS MADE AWARE. EXPLANT DATE: SEVERAL MONTHS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5110670.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT OPTED FOR A LUMBAR FUSION AND DURING THE INITIAL PROCEDURE, THE PHYSICIAN INADVERTENTLY CLIPPED ONE OF THE LEADS TO THE STIMULATOR. OVER THE NEXT SEVERAL MONTHS, THE PATIENT STARTED TO HAVE A NON DEVICE RELATED PAIN IN THE RIGHT BUTTOCK. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348892 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 340544 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention