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

Model Number UNK_NAV_SYS

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

Patient Problem Hematoma (1884)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patients in the study.Patient weight not available from the site.Event date is the date the article was accepted for publication.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and is therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is dependent on the device lot/serial number, therefore is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Bertuccio, a., elia, a., robba, c., scaglione, g., longo, g.P., sgubin, d., vitali, m., barbanera, a.Frameless stereotactic biopsy with dti-based tractography integration: how to adjust the trajectory¿a case series.World neurosurgery 2020 143: 346-352 https://d oi.Org/10.1016/j.Wneu.2020.08.0 background: frameless stereotactic biopsy represents a minimally invasive procedure used for the histopathological diagnosis of brain tumors or to safely approach deep-seated lesions near eloquent areas not amenable for classical neurosurgical procedures.Traditionally, biopsy is performed relying on anatomical landmarks, but it can lead itself to intra- and postoperative complications, such as hemorrhage and fiber disruption.Diffusion tensor imaging (dti) tractography represents a useful tool that can analyze the individual fiber tract conformation in cases of brain tumor and consequently identify the best biopsy trajectory, preserving white matter pathways.In our study, we present a novel technique that is based on the use of preoperative dti for biopsy.Methods: between january 2018 and january 2020, data about patients who underwent frameless biopsy using dti tractography were retrospectively reviewed.The inclusion criterion was adult patients eligible for elective surgery for a single or multiple deep-seated lesions with contraindications to complete surgical resection.Results: we included 12 patients (mean age of 67.9 [ 9.6] years).A single cranial lesion was detected in 7 cases, and multiple lesions in 5 cases.The use of dti enabled the identification of white matter pathways in all cases and adjustment of the biopsy trajectory based on anatomical landmarks in 7 cases.Postoperative hematoma was reported in 1 case, and histological diagnosis was obtained in 11 cases.Conclusion: according to our results, tractography is a useful tool that can enhance the safety of cerebral lesions biopsy sparing any fiber tract damages.Reportable events: in 1 case, a postoperative hematoma was reported and was conservatively managed.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12584504
• MDR Text Key: 274989591
• Report Number: 1723170-2021-02443
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 68 YR