BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2241399 · Received September 9, 2011

    Report

    Report Number
    3006630150-2011-01430
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    November 9, 2009
    Report Date
    November 9, 2009
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD REVEALED 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 PATIENT'S PADDLE LEAD WAS EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PADDLE LEAD EXPLANT WAS BECAUSE THE PATIENT HAS A SMALL EPIDURAL SPACE AND THE PADDLE LEAD WAS CAUSING DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention