BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8705544 · Received June 17, 2019

    Report

    Report Number
    3006630150-2019-02829
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER:SC-8120-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 216390A, MODEL/CATALOG DESCRIPTION: ARTISAN SURGICAL LEAD 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INEFFICACY. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498269 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 186767 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention