BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOVA 2000

    MDR report key: 2652138 · Received April 26, 2012

    Report

    Report Number
    9611343-2012-00017
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    March 27, 2012
    Report Date
    April 17, 2012
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    JAA
    PMA / PMN Number
    K022322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A MEDWATCH REPORT THAT A "PT SCHEDULED ON (B)(6) 2012, FOR A BIVENTRICULAR IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) IMPLANT WITH NO LEFT VENTRICULAR (LV) LEAD. PT HAD A F/U APPOINTMENT WITH THE ATTENDING PHYSICIAN ON (B)(6) 2012, AND THE NURSE ASSISTING THE PHYSICIAN NOTED A LARGE AREA OF RED SKIN ON THE PT'S BACK. THE DETAILS OF (B)(6) 2012, CASE WERE REVIEWED BY THE RADIATION SAFETY OFFICER ON (B)(6) 2012. CASE BEGUN AT 8:25 AND CONCLUDED AT 14:57 ON (B)(6) 2012. A TOTAL OF 150.18 MINUTES OF FLUOROSCOPY WAS USED DURING THE CASE, 34 CINE RUNS WERE TAKEN, 17 STILL PICTURES WERE CAPTURED, THE TOTAL DOSE ARE PRODUCT (DAP) IN CGY. CM2 WAS 138,622, AND THE EXPOSURE DOSE 9595 MGY. PT WAS INFORMED OF THE RADIATION BURN, SUBSEQUENTLY THE PT'S REFERRING PHYSICIAN WAS NOTIFIED". GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOVA 2000 FLUOROSCOPIC X-RAY IMAGING SYSTEM JAA GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other