BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 18742246 · Received February 20, 2024

    Report

    Report Number
    3006630150-2024-00845
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    February 9, 2024
    Report Date
    March 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832676
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: (B)(6). BATCH: 7121098, 7114483, 7121086, AND 7121085.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138550. MODEL: SC-3138-55 . SERIAL: (B)(6). BATCH: 7121098, 7114483, 7121086, AND 7121085.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO DAYS POST IMPLANT OF THE COVERAGE 32 PADDLE LEAD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA. THE CAUSE OF THE HEMATOMA HAS NOT BEEN DETERMINED, AND IT IS UNKNOWN WHAT IF ANY INTERVENTION WAS PROVIDED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE PADDLE LEAD AND FOUR LEAD EXTENSIONS WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO DAYS POST IMPLANT OF THE COVEREDGE 32 PADDLE LEAD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA. THE CAUSE OF THE HEMATOMA HAS NOT BEEN DETERMINED, AND IT IS UNKNOWN WHAT IF ANY INTERVENTION WAS PROVIDED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE PADDLE LEAD AND FOUR LEAD EXTENSIONS WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY. IT WAS ADDITIONALLY REPORTED THAT THE LOCATION OF THE HEMATOMA WAS THE BACK EPIDURAL SPACE, CAUSING THE PATIENT LOSS OF MOTOR FUNCTION. THE PHYSICIAN STATED THAT THE CAUSE OF THE HEMOATOMA MIGHT BE DUE TO PROCEDURE AND NOT THE DEVICE, AND THE PATIENT BEING THIN AND OLDER. DRAINAGE OF THE BLOOD WAS ALSO PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398488 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-70 7075280 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention