BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 7908553 · Received September 25, 2018

    Report

    Report Number
    3006630150-2018-61047
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    August 31, 2018
    Report Date
    September 25, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. MODEL NUMBER/CATALOG NUMBER: SC-2218-50E. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: 5032591. MODEL/CATALOG DESCRIPTION: LINEAR ST TRIAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NECK PAIN. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND WAS PRESCRIBED BY THE PHYSICIAN WITH MEDROL DOSE PACK. THE PATIENTS NECK PAIN WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745769 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E 21310615 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention