BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16837078 · Received April 28, 2023

    Report

    Report Number
    3006630150-2023-02369
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    April 5, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7121230.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, THE PATIENTS LEFT LEG COULD NOT MOVED. THE PATIENT COMPLAINED OF MOTOR FUNCTION ISSUES FOR ABOUT AN HOUR IN THE POST ANESTHESIA CARE UNIT (PACU). THE PATIENT UNDERWENT AN EXPLORATORY SURGERY PROCEDURE AND IT WAS FOUND OUT THAT THE PATIENT HAD AN EPIDURAL HEMATOMA. THE PATIENT THEN UNDERWENT AN EXPLANT PROCEDURE AND THE DEVICES WERE EXPLANTED. HOWEVER, THE PATIENT HAS NOT REGAINED FUNCTION OF THEIR LEFT LEG. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275363 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 563514 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention