MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RENAISSANCE SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number TPL0038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage, Extradural (1890)

Event Date 06/12/2015

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off the date of publication of the article as the actual event date was not provided.The reported event was from the following literature article: grimm f, naros g, gutenberg a, keric n, giese a, gharabaghi a.Blurring the boundaries between frame-based and frameless stereotaxy: feasibility study for brain biopsies performed with the use of a head-mounted robot.Journal of neurosurgery.2015.Doi: 10.3171/2014.12.Jns141781.If information is provided in the future, a supplemental report will be issued.

Event Description

The following event was reported in literature: abstract: frame-based stereotactic interventions are considered the gold standard for brain biopsies, but they have limitations with regard to flexibility and patient comfort because of the bulky head ring attached to the patient.Frameless image guidance systems that use scalp fiducial markers offer more flexibility and patient comfort but provide less stability and accuracy during drilling and biopsy needle positioning.Head-mounted robot¿guided biopsies could provide the advantages of these 2 techniques without the downsides.The goal of this study was to evaluate the feasibility and safety of a robotic guidance device, affixed to the patient¿s skull through a small mounting platform, for use in brain biopsy procedures.This was a retrospective study of 37 consecutive patients who presented with supratentorial lesions and underwent brain biopsy procedures in which a surgical guidance robot was used to determine clinical outcomes and technical procedural operability.The portable head-mounted device was well tolerated by the patients and enabled stable drilling and needle positioning during surgery.Flexible adjustments of predefined paths and selection of new trajectories were successfully performed intraoperatively without the need for manual settings and fixations.The patients experienced no permanent deficits or infections after surgery.The head-mounted robot¿guided approach presented here combines the stability of a b one-mounted set-up with the flexibility and tolerability of frameless systems.By reducing human interference (i.E., manual parameter settings, calibrations, and adjustments), this technology might be particularly useful in neurosurgical interventions that necessitate multiple trajectories.Reported events: one patient undergoing cranial biopsy experienced an epidural hematoma.During the procedure, a 3 mm drill hole had was created followed by a stab incision of the dura.The hematoma was revealed on postoperative ct images and required a craniotomy.The patient did not experience any postoperative deficits.

• Brand Name: RENAISSANCE SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8904419
• MDR Text Key: 156294529
• Report Number: 1723170-2019-04512
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention