BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 10821399 · Received November 11, 2020

    Report

    Report Number
    3006630150-2020-05478
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    September 18, 2020
    Report Date
    November 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 5153664/7071284.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNDESIRED SENSATION CAUSED BY THE STIMULATION AND PAIN. IT WAS ALSO STATED THAT THE IPG WAS BOTHERING THE PATIENT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288692 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 251797 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention