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 Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Dysphasia (2195); Swelling/ Edema (4577)

Event Date 03/27/2021

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.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

Mariani, v., sartori, i., revay, m., mai, r., lizio, d., berta, l., rizzi, m., cossu, m.Intraoperative corticocortical evoked potentials for language monitoring in epilepsy surgery.World neurosurgery.2021 151: (e109-e121).Https://doi.Org/10.1016/j.Wneu.2021.03.1 -objective: to evaluate the applicability of corticocortical evoked potentials (ccep) for intraoperative monitoring of the language network in epilepsy surgery under general anesthesia.To investigate the clinical relevance on language functions of intraoperative changes of ccep recorded under these conditions.- methods: ccep monitoring was performed in 14 epileptic patients (6 females, 4 children) during resections in the left perisylvian region under general anesthesia.Electrode strips were placed on the anterior language area (al) and posterior language area (pl), identified by structural and functional magnetic resonance imaging.Singlepulse electric stimulations were delivered to pairs of adjacent contacts in a bipolar fashion.During resection, we monitored the integrity of the dorsal language pathway by stimulating either al by recording ccep from pl or vice versa, depending on stability and reproducibility of ccep.We evaluated the first negative (n1) component of ccep before, during, and after resection.- results: all procedures were successfully completed without adverse events.The best response was obtained from al during stimulation of pl in 8 patients and from pl during stimulation of al in 6 patients.None of 12 patients with a postresection n1 amplitude decrease of 0%e15% from baseline presented postoperative language impairment.Decreases of 28% and 24%, respectively, of the n1 amplitude were observed in 2 patients who developed transient postoperative speech disturbances.- conclusions: the application of ccep monitoring is possible and safe in epilepsy surgery under general anesthesia.Putative al and pl can be identified using noninvasive presurgical neuroimaging.Decrease of n1 amplitude >15% from baseline may predict postoperative language deficits.Reportable events two patients, who presented with normal language performances in the immediate postoperative period, developed late relevant language impairment in the subsequent hours, because of occurrence of local hemorrhagic (case 9) and edematous (case 5) complications, respectively.Recovery of normal language functions occurred within 6 months.The 2 remaining patients (cases 1 and 6) showed immediate postoperative speech disturbances.At awakening, one patient showed phonemic paraphasia and naming impairment.At clinical follow-up, a normal language function was fully recovered 3 months after discharge in case 6 the systemic arterial blood pressure was progressively increased for testing hemostasis.

• 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: 12857278
• MDR Text Key: 285929188
• Report Number: 1723170-2021-02737
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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
• Date Manufacturer Received: 11/18/2021
• 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: 25 YR
• Patient Sex: Male