BRAINLAB ELEMENTS IMAGE FUSION, 5.0

Additional Manufacturer Narrative

B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE ELECTRODE LEADS WERE PLACED IN A DIFFERENT LOCATION IN THE BRAIN THAN INTENDED WITH THE BRAINLAB STEREOTACTIC PLANNING INVOLVED, DESPITE ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE DEVIATION OF THE LEADS PLACED WAS DETECTED BY THE SURGEON WITH A POST-OPERATIVE CT SCAN, AND A REVISION SURGERY TOOK PLACE PULLING BACK THE LEADS BY A FEW MM MANUALLY, WITH NO FURTHER CHANGES TO THE EXISTING SURGICAL INVASIVE ACTIONS DONE AT THE ORIGINAL SURGERY. - THE OUTCOME OF THE REVISION SURGERY WAS CONSIDERED SUCCESSFUL AS INTENDED, WITH THE ELECTRODES DEEMED IN AN ACCEPTABLE POSITION. - THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THESE DEVIATING PLACEMENTS. - THERE WERE NO CHANGES TO THE PLANNED PROCEDURE AT THE ORIGINAL SURGERY, AND NO PROLONGATION OF THE ORIGINAL SURGERY/ANESTHESIA. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE REPEAT SURGERY/ANESTHESIA OF CA. 60MIN. - THERE WERE NO FURTHER REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION WAS ALSO NOT PROLONGED. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE ELECTRODES PLACED IN THE BRAIN CA. 5MM DEEPER THAN INTENDED, PLANNED WITH THE BRAINLAB STEREOTAXY TREATMENT PLANNING, IS: - A SIGNIFICANTLY WRONG IMAGE FUSION BETWEEN THE MRI T1 AND THE STEREOTACTICALLY LOCALIZED CT WAS AUTOMATICALLY CALCULATED (AS EXPECTABLE FOR RARE CASES, NOT INDICATING ANY SOFTWARE MALFUNCTION) AND ACTIVELY ACCEPTED BY THE USER WITHOUT HAVING APPLIED THE REQUIRED MANUAL CORRECTION AFTER THE NECESSARY REVIEW, DESPITE THE VISIBLE DISCREPANCY OF THE OVERLAID DISPLAYED DATASETS, NOT FOLLOWING BRAINLAB INSTRUCTIONS. THE DATA PROVIDED FOR THIS SURGERY SHOWS THE DEVIATION OF THIS IMAGE FUSION. THE DEVIATION IS BEST VISIBLE IN THE SAGITTAL RECONSTRUCTION, AND WITH THE AVAILABLE AMBER/BLUE OVERLAY FUNCTION. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE (NAVIGATION). CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE. H7: BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

Description of Event or Problem

A CRANIAL SURGERY FOR TWO DEPTH ELECTRODE PLACEMENTS IN THE BRAIN, TO THE LEFT AND RIGHT VENTRAL INTERMEDIATE NUCLEUS (VIM) INSIDE THE LEFT AND RIGHT THALAMUS, TO TREAT ESSENTIAL TREMOR WITH DEEP BRAIN STIMULATION (DBS), HAS BEEN PLANNED WITH THE BRAINLAB ELEMENTS - IMAGE FUSION 5.0 AND TRAJECTORY PLANNING 2.6 FOR THE ELECTRODE POSITIONS, TO PLACE THEIR LEADS WITH A NON-BRAINLAB STEREOTACTIC ARC/FRAME. FROM EVALUATING THE PLACED ELECTRODE LEADS WITH POST-OPERATIVE CT SCAN, THE SURGEON DETERMINED THAT BOTH ELECTRODES WERE PLACED CA. 5MM DEEPER THAN PLANNED/INTENDED. A REVISION SURGERY WAS PLANNED AND TOOK PLACE ON MAY 1(B)(6)TING SURGICAL INVASIVE ACTIONS DONE AT THE ORIGINAL SURGERY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE OUTCOME OF THE REVISION SURGERY WAS CONSIDERED SUCCESSFUL AS INTENDED, WITH THE ELECTRODES DEEMED IN AN ACCEPTABLE POSITION. - THERE WAS NO DIRECT (OR INCREASED) RISK TO HARM A CRITICAL STRUCTURE DUE TO THESE DEVIATING PLACEMENTS. - THERE WERE NO CHANGES TO THE PLANNED PROCEDURE AT THE ORIGINAL SURGERY, AND NO PROLONGATION OF THE ORIGINAL SURGERY/ANESTHESIA. - THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE REPEAT SURGERY/ANESTHESIA OF CA. 60MIN. - THERE WERE NO FURTHER REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION WAS ALSO NOT PROLONGED.