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 Muscle Weakness (1967)

Event Date 05/21/2020

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 online publishing date of the literature article. Device lot number, or serial number, unavailable. The 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

Citation: josé pedro lavrador, prajwal ghimire, christian brogna, luciano furlanetti, sabina patel, richard gullan, keyoumars ashkan, ranjeev bhangoo, francesco vergani. Pre- and intraoperative mapping for tumors in the primary motor cortex: decision-making process in surgical resection. Journal of neurological surgery. Vol 82. Https://doi. Org/10. 1055/s-0040-1709729. Abstract: background: lesions within the primary motor cortex (m1) and the corticospinal tract (cst) represent a significant surgical challenge with a delicate functional trade-off that should be integrated in the overall patient-centered treatment plan. Methods: patients with lesions within the m1 and cst with preoperative cortical and subcortical mapping (navigated transcranial magnetic stimulation [ntms] and tractography), intraoperative mapping, and intraoperative provisional histologic information (smear with and without 5-aminolevulinic acid [5-ala]) were included. This independently acquired information was integrated in a decision-making process model to determine the intraoperative extent of resection. Results: a total of 10 patients (6 patients with metastatic precentral tumor; 1 patient with grade iii and 2 patients with grade iv gliomas; 1 patient with precentral cavernoma) were included in the study. Most of the patients (60%) had a pre-operative motor deficit. Then tms documented m1 invasion in all cases, and in eight patients, the lesions were embedded within the cst. Overall, 70% of patients underwent gross total resection; 20% of patients underwent near-total resection of the lesions. In only one patient was no surgical resection possible after both preoperative and intraoperative mapping. Overall, 70% of patients remained stable postoperatively, and previous motor weakness improved in 20%. Conclusion: the independently acquired anatomical (anatomical mri) and functional (ntms and fractography) tests in patients with cst lesions provide a useful guide for resection. The inclusion of histologic information (smear with or without 5-ala) further allows the surgical team to balance the potential functional risks within the global treatment plan. Therefore, the patient is kept at the center of the informed decision-making process. Reported event: one patient experienced a post-operative deterioration of their motor weakness/deficit.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13079453
• MDR Text Key: 286230980
• Report Number: 1723170-2021-02960
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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
• Date Manufacturer Received: 12/02/2021
• 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 Treatment Data

Date Received: 12/23/2021 Patient Sequence Number: 1