BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1892226 · Received October 26, 2010

    Report

    Report Number
    3006630150-2010-01819
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 28, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REPROGRAMMING SESSION, THE PATIENT REPORTED THE BSN REP TURNED UP THE STIMULATION AS THE PATIENT STOOD UP WHICH CAUSED THE PATIENT TO FALL, HIT HIS HEAD AGAINST THE WALL AND BE KNOCKED UNCONSCIOUS. THE PATIENT REPORTED HE WAS IN EXCRUCIATING PAIN WHILE THE PHYSICIAN PULLED THE TRIAL LEADS. ACCORDING TO THE BSN REP, THE PATIENT INSISTED ON BEING REPROGRAMMED WHILE STANDING UP. AFTER REPROGRAMMING, WHEN THE PATIENT SAT DOWN, THERE WAS A SURGE OF STIMULATION AND THE PT FELL DOWN. THE PT WAS SCREAMING AND THE BSN REP DISCONNECTED THE LEAD FROM THE ETS. THE BSN REP AND PHYSICIAN CHECKED THE PT'S VITALS, PULLED THE LEADS, AND THE PATIENT WAS SENT HOME DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ST LINEAR TRIAL LEAD, 50CM WITH PRE-LOADED 0.014"| MODEL#: SC-2218-50E, SERIAL #: (B)(4)| STYLET (STREAMLINED)