BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1953738 · Received January 4, 2011

    Report

    Report Number
    3006630150-2010-02217
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT IS EXPERIENCING A SHOCKING SENSATION. AN X RAY TAKEN SHOWED THAT A CONTACT HAS BEEN DISLODGED OFF THE PADDLE LEAD INTO THE EPIDURAL SPACE. ALSO THE PT IS EXPERIENCING IRRITATION FROM THE LOCATION OF THE EXTENSIONS. THE PHYSICIAN REPLACED THE PADDLE LEAD AND EXTENSIONS AND REMOVED THE DISLODGED CONTACT FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention (B)(4)| SCS PHIII EXT 35CM: MODEL#:SC-3138-35,| (B)(4)