BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3011137372-2017-00105

    MDR report key: 6411759 · Received March 16, 2017

    Report

    Report Number
    3011137372-2017-00105
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 16, 2017
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOUND THE LOT PASSED ALL ACCEPTANCE CRITERIA AND THERE WERE NO RELEVANT FINDINGS RELATED TO THE REPORTED EVENT. NO SAMPLE RETURN OR PHOTO PROVIDED. THERE WERE NO ALLEGATIONS OF ANY TYPE OF PRODUCT DEFICIENCY. THERE WAS NO REPORT OF ANY TYPE OF DEVICE DEFICIENCY. THIS DEVICE IS NOT INTENDED FOR USE FOR RADIOFREQUENCEY ABLATION OF SPINAL METASTASES PER OUR IFU. IT HAS BEEN REPORTED AS USED TO PLACE AND DEPLOY A RADIOFREQUENCY ABLATION ELECTRODE, PURPOSES FOR WHICH IT IS NOT INDICATED. AN IN-SERVICE REQUEST/CUSTOMER VISIT WILL BE REQUESTED AS A CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE FEMALE PATIENT A RADIOFREQUENCY ABLATION OF SPINE METASTASES WAS PERFORMED UNDER ANESTHESIA ON (B)(6) 2017. AT THE LEVEL OF THE SECOND LUMBAR VERTEBRAL BODY (LWK) TROCARS WERE INSERTED FROM DORSAL THROUGH THE PEDICLES UNDER FLUOROSCOPY CONTROL. THE CORRECT POSITION AND ORIENTATION OF THE TROCARS WERE VERIFIED SEVERAL TIMES BY MEANS OF IMAGING. THEN AN ELECTRODE WAS INSERTED IMAGE-CONTROLLED THROUGH EACH TROCAR INTO THE 2ND LUMBAR VERTEBRAL BODY (LWK). THE CORRECT POSITION WAS IMAGING-PROVEN. AFTERWARDS THE RADIO FREQUENCY ABLATION WAS CARRIED OUT AND MATERIAL WAS REMOVED. AFTER THE INTERVENTION AND AFTER WAKING UP FROM ANESTHESIA THE PATIENT WAS DIAGNOSED WITH A PARAPLEGIA FROM THE 2ND LUMBAR VERTEBRAL BODY. IN THE SUBSEQUENT MRI DIAGNOSTICS BLEEDINGS WERE EXCLUDED, IT WAS NOTED A STRONG CONTRAST MEDIUM INTAKE OF THE NERVES IN THIS AREA (CAUDA FIBRES). SINCE A DIRECT MECHANICAL INJURY TO THE NERVE FIBERS DURING THE INSERTION OF THE INSTRUMENTS CAN BE EXCLUDED BY MEANS OF IMAGING, FOR THE DEVELOPMENT OF THE COMPLICATION A TECHNICAL PROBLEM MUST BE TAKEN INTO CONSIDERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE FEMALE PATIENT A RADIOFREQUENCY ABLATION OF SPINE METASTASES WAS PERFORMED UNDER ANESTHESIA ON (B)(6) 2017. AT THE LEVEL OF THE SECOND LUMBAR VERTEBRAL BODY (LWK) TROCARS WERE INSERTED FROM DORSAL THROUGH THE PEDICLES UNDER FLUOROSCOPY CONTROL. THE CORRECT POSITION AND ORIENTATION OF THE TROCARS WERE VERIFIED SEVERAL TIMES BY MEANS OF IMAGING. THEN AN ELECTRODE WAS INSERTED IMAGE-CONTROLLED THROUGH EACH TROCAR INTO THE 2ND LUMBAR VERTEBRAL BODY (LWK). THE CORRECT POSITION WAS IMAGING-PROVEN. AFTERWARDS THE RADIO FREQUENCY ABLATION WAS CARRIED OUT AND MATERIAL WAS REMOVED. AFTER THE INTERVENTION AND AFTER WAKING UP FROM ANESTHESIA THE PATIENT WAS DIAGNOSED WITH A PARAPLEGIA FROM THE 2ND LUMBAR VERTEBRAL BODY. IN THE SUBSEQUENT MRI DIAGNOSTICS BLEEDINGS WERE EXCLUDED, IT WAS NOTED A STRONG CONTRAST MEDIUM INTAKE OF THE NERVES IN THIS AREA (CAUDA FIBRES). SINCE A DIRECT MECHANICAL INJURY TO THE NERVE FIBERS DURING THE INSERTION OF THE INSTRUMENTS CAN BE EXCLUDED BY MEANS OF IMAGING, FOR THE DEVELOPMENT OF THE COMPLICATION A TECHNICAL PROBLEM MUST BE TAKEN INTO CONSIDERATION.

    Patients

    Seq Age Sex Outcome Treatment
    1