BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 20257455 · Received September 19, 2024

    Report

    Report Number
    3006630150-2024-06254
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 27, 2024
    Report Date
    February 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12160, MODEL: SC-1216. SERIAL: (B)(6). BATCH: (B)(6).

    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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7120787.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEADS HAD FRACTURED DUE TO IMPEDANCES. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE. IT WAS NOTED THAT PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND WAS NOT ABLE TO GET ENOUGH PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEADS HAD FRACTURED DUE TO IMPEDANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEADS HAD FRACTURED DUE TO IMPEDANCES. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE. IT WAS NOTED THAT PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND WAS NOT ABLE TO GET ENOUGH PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489253 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7119882 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention| O