BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 19767467 · Received July 17, 2024

    Report

    Report Number
    3006630150-2024-04640
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 12, 2024
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    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: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7076840, 7076848, 7076400, 7075729, 7072990, 7073253, 7073271. PRODUCT FAMILY: SCS-IPG-R-MRI UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 541825. PRODUCT FAMILY: SCS-ADAPTERS UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 7051470, 7057602.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A REVISION PROCEDURE (MFR. REPORT NUMBER 3006630150-2024-03351) THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND A NEW PAIN THAT PERSISTED WHICH CAUSED HER TO BE HOSPITALIZED. THE PATIENT WAS GIVEN AN INJECTION BUT NO REPRIEVE. THE PLAN WAS FOR THE PATIENT TO HAVE A REVISION PROCEDURE, BUT WHEN THE PATIENT UNDERWENT THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A NON-BOSTON SCIENTIFIC PADDLE LEAD THAT WAS GROWN INTO/STUCK TO HER DURA. THEREFORE, THE PHYSICIAN DID NOT FEEL IT WAS SAFE TO PLACE A NEW PADDLE BACK IN THE SPACE AND THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS THEN EXPLANTED INSTEAD. THE HOSPITAL RETAINED ALL EXPLANTED DEVICES AND WILL NOT BE RETURNED FOR ANALYSIS. POST OPERATIVELY, THE PATIENT WAS RECOVERING WITHOUT POST OPERATIVE COMPLICATION. HOWEVER, A COUPLE DAYS AFTER THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLI. THE PATIENT WAS PLACED ON ANTICOAGULANTS. THE PATIENT WAS IN OTHERWISE GOOD SPIRITS AND WAS BEING MONITORED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180586 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 369499 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1