BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 19661431 · Received July 2, 2024

    Report

    Report Number
    3006630150-2024-04255
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832669
    PMA / PMN Number
    P030017
    Adverse Event
    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(S) INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7082112. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7082414. PRODUCT FAMILY: SCS-EXTENSION.. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7084018. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7084188..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY HALF HOUR FOLLOWING THE SPINAL CORD STIMULATION (SCS) PERMANENT TRIAL PROCEDURE, THE PATIENT COULD NOT MOVE HIS RIGHT LEG. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM, AND ALL DEVICES WERE REMOVED. THERE WAS NO DEVICE MALFUNCTION SUSPECTED AND NO REPORT OF ANYTHING HAPPENING DURING THE SCS PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE ISSUE. THE EXPLANTED DEVICES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. THE PATIENT HAD SOME IMPROVEMENT, BUT WEAKNESS REMAINS. THE PATIENT STARTED PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800044 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-50 7086821 08714729832669

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention