BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 18383691 · Received December 22, 2023

    Report

    Report Number
    3006630150-2023-08084
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832669
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14320. MODEL: SC-1432. SERIAL: (B)(6). LOT: 223438.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS IN THE LEGS A DAY AFTER THE SPINAL CORD STIMULATION PADDLE LEAD IMPLANT PROCEDURE. THE PATIENT WAS ADVISED TO GO TO THE HOSPITAL IMMEDIATELY, HOWEVER, THE PATIENT WENT THE FOLLOWING DAY AND THEN UNDERWENT A PROCEDURE WHERE THE PADDLE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PARALYSIS AND DID NOT REGAIN FEELING IN THE LEGS. THE PATIENT WILL BE ADMITTED FOR POSTOPERATIVE NEUROLOGICAL REHABILITATION. THERE WERE NO REPORTED COMPLICATIONS DURING THE IMPLANT PROCEDURE, HOWEVER, THE PHYSICIAN ASSESSED THE EVENT WAS PROCEDURE RELATED AS A HEMATOMA DEVELOPED UNDER THE PADDLE LEAD AFTER IT HAD INITIALLY BEEN PLACED. THERE WERE NO ISSUES WITH THE IPG. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296772 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-50 7084649 08714729832669

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| O| H