BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20138808 · Received September 4, 2024

    Report

    Report Number
    3006630150-2024-05873
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7090115. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12160. MODEL: SC-1216. SERIAL: (B)(6). BATCH: 564485.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734470 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7090388 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention