BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8458452 · Received March 27, 2019

    Report

    Report Number
    3006630150-2019-01371
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    July 2, 2009
    Report Date
    March 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8120-70; SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 232572A; MODEL/CATALOG DESCRIPTION: ARTISAN SURGICAL LEAD 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LEG WEAKNESS AFTER THE LEAD WAS IMPLANTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250360 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 185914 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention