BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-6

    MDR report key: 22093064 · Received May 27, 2025

    Report

    Report Number
    3006630150-2025-03713
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    January 29, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <QRB>. B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 16494778, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 16505320, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 16494778, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <QRB>. B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R UPN: M365SC11600 MODEL: SC-1160 SERIAL: (B)(6) BATCH: 372173 UDI: (01)08714729951254(17)220820(10)372173(21)372173 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: 3145190 BATCH: 3145190 UDI: (01)08714729789567(17)211008(10)3145190(21)3145190 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: 1003922 BATCH: 16494778 UDI: (01)08714729789567(17)151106(10)16494778(21)1003922 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: 1003739 BATCH: 16505320 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(6) BATCH: 16494778 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE DUE TO CHARGING DIFFICULTIES WITH THE IMPLANTABLE PULSE GENERATOR (IPG). ADDITIONALLY, THE LEADS MIGRATED, RESULTING IN INADEQUATE STIMULATION, WHICH PREVENTED THE PATIENT FROM EXPERIENCING SUFFICIENT PAIN RELIEF. THE PATIENT UNDERWENT AN IPG AND LEADS REVISION PROCEDURE WHEREIN THEIR IPG AND LEADS WERE EXPLANTED AND REPLACED. THE DEVICES WERE DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING BETTER AND SATISFIED WITH THE NEW DEVICES. ELECTROCAUTERY WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE DUE TO CHARGING DIFFICULTIES WITH THE IMPLANTABLE PULSE GENERATOR (IPG). ADDITIONALLY, THE LEADS MIGRATED, RESULTING IN INADEQUATE STIMULATION, WHICH PREVENTED THE PATIENT FROM EXPERIENCING SUFFICIENT PAIN RELIEF. THE PATIENT UNDERWENT AN IPG AND LEADS REVISION PROCEDURE WHEREIN THEIR IPG AND LEADS WERE EXPLANTED AND REPLACED. THE DEVICES WERE DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING BETTER AND SATISFIED WITH THE NEW DEVICES. ELECTROCAUTERY WAS USED. ADDITIONAL INFORMATION INDICATES THAT IN 2013, THE PATIENT UNDERWENT AN IMPLANT PROCEDURE IN WHICH THREE SC-2366-70 LEADS WERE IMPLANTED. SUBSEQUENTLY, IN 2020, A PROCEDURE WAS REPORTED IN WHICH ONE SC-2366-70 LEAD (WHOSE SERIAL NUMBER IS UNKNOWN) WAS REPLACED DUE TO HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327579 LINEAR? 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2366-50 16444931 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention