BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1864307 · Received October 7, 2010

    Report

    Report Number
    3006630150-2010-01685
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL IMPLANT THE PT WAS EXPERIENCING NUMBNESS IN HER LEFT LEG WHEN HER STIMULATION WAS ON. THE TRIAL LEADS WERE REMOVED. THE PHYSICIAN COULD NOT DETERMINE THE REASON FOR THE NUMBNESS. THE PT REPORTED THAT THE NUMBNESS HAS DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2158-50T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention MODEL #: SC-2158-50T,| LINEAR TRIAL LEAD, 50CM W/PRE-LOADED 0.014" STYLET| SERIAL #: (B)(4)