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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameMEDTRONIC NAVIGATION
Type of DeviceNEUROLOGICAL 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 Key12857278
MDR Text Key285929188
Report Number1723170-2021-02737
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
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 Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
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 Treatment Data
Date Received: 11/22/2021 Patient Sequence Number: 1
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