BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 20276170 · Received September 22, 2024

    Report

    Report Number
    3006630150-2024-06339
    Event Type
    Injury
    Date Received
    September 22, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832669
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7083007/7074395/7083252/7083523.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE THE PATIENT DEVELOPED WEAKNESS IN BOTH LEGS. IT WAS NOTED THAT THE PATIENT DEVELOPED HEMATOMA FROM SURGERY. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495932 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-50 7087444 08714729832669

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention