BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19085371 · Received April 10, 2024

    Report

    Report Number
    3006630150-2024-02264
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7071016. BRAND NAME: INFINION CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7071830.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT A PROCEDURE WHERE THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368835 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 367434 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention