MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.5) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 26615-01A

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths were applied in a different location in the brain than anticipated, with the brainlab device involved, despite no negative clinical effect to the patient was reported by the hospital/surgeon, nor any medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue. Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable. A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending. Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

A cranial surgery for placement of bilateral rns (responsive neurostimulation) leads in the occipitofrontal region of the brain has been performed with the aid of the brainlab navigation software cranial 3. 5 (on apr 29, 2021). A pre-operative ct scan with a combination of bone and adhesive fiducials was acquired before the surgery, to use with and register to the navigation. A trajectory was planned. During the procedure the surgeon: performed the initial patient registration on the pre-operative ct via the fiducials fixated on the patient's head, to match the display of the navigation to the current patient anatomy. Verified the accuracy of the registration thoroughly and accepted the registration to proceed. Acquired the bone fiducials as intraoperative landmarks. Draped the patient and exchanged the unsterile reference array for a sterile one. Verified the accuracy of the registration and used the intraoperative landmarks to update the registration. Proceeded to place the left-side lead/electrode: aligned the varioguide to the pre-planned trajectory, passed the biopsy needle to mark the incision site, made the incision, passed a drill through the varioguide and drilled the entry for the lead, measured the distance to target using the biopsy needle, passed the electrode to the target depth using a cannula and stylet. Repeated these steps for the right-side lead/electrode. Upon review of the post-operative scan, the surgeon detected a deviation of the first lead placed (left) from the intended position (entry point deviated by about 4mm, target point by about 5. 5-6mm). The second lead placed (right) was nearly identical to the planned trajectory. No negative clinical effect to the patient was reported by the hospital/surgeon, nor any medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.5)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 11884857
• MDR Text Key: 261746672
• Report Number: 8043933-2021-00036
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 26615-01A
• Device Catalogue Number: 26615-01A
• Device Lot Number: SW V. 3.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 05/26/2021 Patient Sequence Number: 1