BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2052338 · Received April 12, 2011

    Report

    Report Number
    3006630150-2011-00493
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2366-70 SERIAL#: (B)(4) MODEL DESCRIPTION: LINEAR 3-6 LEAD 70CM.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE DURING THE IMPLANT AFTER THE PHYSICIAN IMPLANTED THE LEADS THE PATIENT COMPLAINED OF SEVERE LEG PAIN. THE PHYSICIAN REMOVED THE LEADS AND ABORTED THE IMPLANT PROCEDURE. THE PATIENT WAS GIVEN AN ORAL STEROID AND WAS REPORTEDLY DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE DURING THE IMPLANT AFTER THE PHYSICIAN IMPLANTED THE LEADS THE PATIENT COMPLAINED OF SEVERE LEG PAIN. THE PHYSICIAN REMOVED THE LEADS AND ABORTED THE IMPLANT PROCEDURE. THE PATIENT WAS GIVEN AN ORAL STEROID AND WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention