BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15420317 · Received September 14, 2022

    Report

    Report Number
    3006630150-2022-04744
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    June 4, 2018
    Report Date
    September 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(4). BATCH: 5031347. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12000. MODEL: SC-1200. SERIAL: (B)(4). BATCH: 353801.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEAD SITE. IT WAS NOT KNOWN IF INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PUT ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE EXPLANTED. ALL EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364940 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5014345 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention