BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2003836 · Received February 24, 2011

    Report

    Report Number
    3006630150-2011-00263
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS 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 WAS EXPERIENCING NAUSEA WHEN HIS STIMULATION WAS ON. THE BSN SALES REP WAS ABLE TO SUCCESSFULLY REPROGRAM THE PT AND THE PT WAS EXPERIENCING LESS OVERSTIMULATION ON THE RIGHT OCCIPITAL NERVE. THE PHYSICIAN'S ASSISTANT (PA) NOTED SWELLING ON THE RIGHT SIDE AND ADMINISTERED AN INJECTION FOR PAIN. THE PA DID NOT BELIEVE THE SWELLING WAS DEVICE RELATED. THE PATIENT WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NAUSEA WHEN HIS STIMULATION WAS ON. THE BSN SALES REPRESENTATIVE WAS ABLE TO SUCCESSFULLY REPROGRAM THE PATIENT AND THE PATIENT WAS EXPERIENCING LESS OVERSTIMULATION ON THE RIGHT OCCIPITAL NERVE. THE PHYSICIAN'S ASSISTANT (PA) NOTED SWELLING ON THE RIGHT SIDE AND ADMINISTERED AN INJECTION FOR PAIN. THE PA DID NOT BELIEVE THE SWELLING WAS DEVICE RELATED. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention (B)(4)| MODEL # SC-2218-70| (B)(4)| (B)(4)| LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012" STYLET| ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET| MODEL# SC-2138-70