BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20444348 · Received October 14, 2024

    Report

    Report Number
    3006630150-2024-06942
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    December 6, 2023
    Report Date
    December 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    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

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6)/(B)(6)/(B)(6); BATCH: 20162179/7077082/7133851. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6); BATCH: 5098749.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE (MFR. REPORT NO. 3006630150-2024-06941), THE COVERAGE WAS NOT OBTAINED. X-RAY WAS TAKEN AND REVEALED THAT THE SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE. (MFR. REPORT NO. 3006630150-2024-06941), THE COVERAGE WAS NOT OBTAINED. X-RAY WAS TAKEN AND REVEALED SPINAL CORD STIMULATION (SCS) LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT EXPLANTED PRODUCTS WERE NOT RELEASED BY FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811455 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 20162179 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention