BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2180021 · Received July 27, 2011

    Report

    Report Number
    3006630150-2011-01153
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL AND PERFORMANCE TESTS DONE. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED LEADS AND EXTENSIONS REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-8116-50 SERIAL#: (B)(4) DESCRIPTION: SCS PADDLE LEAD - 50CM. MODEL#:SC-3138-25 SERIAL#: (B)(4) DESCRIPTION:SCS PHIII EXT 25CM .THE EXPLANTED PADDLE LEAD AND EXTENSIONS WILL NOT BE RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO PAIN AT THE POCKET SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO PAIN AT THE POCKET SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention