BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 21940153 · Received April 30, 2025

    Report

    Report Number
    3006630150-2025-02955
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    February 14, 2025
    Report Date
    April 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 5019484. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 5012254. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 5029192. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC11320. MODEL: SC-1132. SERIAL: (B)(6). BATCH: 203354. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK H6. 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-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6). BATCH: 5019484 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6). BATCH: 5012254 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6). BATCH: 5029192 UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R UPN: M365SC11320 MODEL: SC-1132 SERIAL: (B)(6). BATCH: 203354 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND EXPERIENCED CHANGES IN PAIN RELIEF. AN X-RAY REVEALED THAT THE SPINAL CORD STIMULATOR LEADS HAD MIGRATED AND WERE IMPACTING THE SPINOUS PROCESS, POSING A RISK OF BREAKAGE. THE PATIENT UNDERWENT AN IPG AND SPINAL CORD STIMULATOR LEAD REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE CERVICAL LEADS WERE REPOSITIONED. POST-OPERATIVELY, THE PATIENT WAS DOING WELL. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND EXPERIENCED CHANGES IN PAIN RELIEF. AN X-RAY REVEALED THAT THE SPINAL CORD STIMULATOR LEADS HAD MIGRATED AND WERE IMPACTING THE SPINOUS PROCESS, POSING A RISK OF BREAKAGE. THE PATIENT UNDERWENT AN IPG AND SPINAL CORD STIMULATOR LEAD REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE CERVICAL LEADS WERE REPOSITIONED. POST-OPERATIVELY, THE PATIENT WAS DOING WELL. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372057 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 21314056 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1