BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 16315652 · Received February 7, 2023

    Report

    Report Number
    3006630150-2023-00464
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    April 28, 2019
    Report Date
    February 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED A BLOOD CLOT FIVE DAYS AFTER HER SPINAL CORD STIMULATION, SCS, IMPLANT PROCEDURE. IT WAS STATED THAT THE PAIN IN HER LEFT LEG WAS SO BAD THAT SHE CALLED FOR AN AMBULANCE-HELICOPTER. THE PATIENT STATED THAT THE LEFT LEG WAS PURPLE AND WAS THE SIZE OF A HUGE HAM HOG. SHE ALSO REPORTED THAT HER TOES WERE THE SIZE OF SAUSAGES. SHE WAS ADMITTED TO THE HOSPITAL IN THE INTENSIVE CARE UNIT FOR SIX DAYS. DURING HER HOSPITAL STAY THE PATIENT UNDERWENT SURGERY TO REMOVE THE CLOTS IN HER LEG AND WAS GIVEN A MEDICATION CALLED ELIQUIS FOR SEVERAL MONTHS AFTER. THE PATIENT REPORTED THAT HER HEARTBEAT WAS LIKE A BUTTERFLY AND THEREFORE REQUIRED A DEFIBRILLATOR TO STABILIZE. THE PATIENT NOTED THAT SHE ALSO HAD CLOTS IN HER LUNGS THAT WERE NOT OPERATED ON. THE PHYSICIAN ASSESSED THAT THE BLOOD CLOTS WERE DUE TO THE PATIENT TAKING CHEWABLE ASPIRIN AT THE TIME OF SURGERY. IN ADDITION, THE PATIENT HAD A FAMILY HISTORY OF BLOOD CLOTS. THE PHYSICIAN BELIEVES THE SCS IMPLANT SURGERY EXACERBATED THESE SYMPTOMS AND WAS NOT DEVICE RELATED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316228 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 341645 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R