BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 15940977 · Received December 8, 2022

    Report

    Report Number
    3006630150-2022-06816
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    October 1, 2022
    Report Date
    January 4, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7075354. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7076222. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7076486. PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14320. MODEL: SC-1432. SERIAL: (B)(6). BATCH: 211869.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED PAIN IN HER RIGHT THORACIC AREA WHEN HER RIGHT LEAD WAS TURNED ON. THE PATIENT'S PAIN WOULD DISSIPATE WHEN THE STIMULATION OF THE RIGHT LEAD WAS TURNED OFF. THE PATIENT'S DEVICE WAS REPROGRAMMED, HOWEVER, THE REPORTED ISSUE PERSISTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE HER SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED PAIN IN HER RIGHT THORACIC AREA WHEN HER RIGHT LEAD WAS TURNED ON. THE PATIENT'S PAIN WOULD DISSIPATE WHEN THE STIMULATION OF THE RIGHT LEAD WAS TURNED OFF. THE PATIENT'S DEVICE WAS REPROGRAMMED, HOWEVER, THE REPORTED ISSUE PERSISTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE HER SYSTEM WAS EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE DEVICES WERE NOT RETURNED AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449939 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7074609 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention