BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 16577234 · Received March 20, 2023

    Report

    Report Number
    3006630150-2023-01320
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    January 16, 2023
    Report Date
    May 2, 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

    THE LEADS (SC-2366-70, SERIAL NUMBER 1000672, (B)(6) WERE NOT RETURNED; THEREFORE, A TECHNICAL PRODUCT ANALYSIS OF THE DEVICES COULD NOT BE COMPLETED. THE RETURNED IMPLANTABLE PULSE GENERATOR (IPG) (SC-1132, SERIAL NUMBER (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: N/I . PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 16224220. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 16261348. PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC11320. MODEL: SC-1132. SERIAL: (B)(4). BATCH: N/I.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 16224220. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 16261348. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 16338671. PRODUCT FAMILY: SCS-IPG-R UPN: M365SC11320, MODEL: SC-1132, SERIAL: (B)(6), BATCH: 16341581.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION A SPINAL CORD STIMULATION (SCS) LEAD DUE TO INADEQUATE STIMULATION AND LEAD MIGRATION. FOUR LEADS AND AN IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED AND DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION A SPINAL CORD STIMULATION (SCS) LEAD DUE TO INADEQUATE STIMULATION AND LEAD MIGRATION. FOUR LEADS AND AN IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED AND DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION A SPINAL CORD STIMULATION (SCS) LEAD DUE TO INADEQUATE STIMULATION AND LEAD MIGRATION. FOUR LEADS AND AN IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED AND DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355090 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 16363561 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention