BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE X 32

    MDR report key: 17637434 · Received August 28, 2023

    Report

    Report Number
    3006630150-2023-04963
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832690
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7081924. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7081909. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7080480. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7108915.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEW HOURS AFTER THE SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INCREASED BLOOD LOSS AND PARALYSIS IN THE LEGS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE PADDLE LEAD AND LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS TRANSFERRED TO A REHABILITATION CENTER POSTOPERATIVELY. THE LOCATION OF THE LEAD AND AREA OF BLOOD LOSS WAS UNABLE TO BE OBTAINED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339208 COVEREDGE X 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8352-70 7071075 08714729832690

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability| R