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); Unspecified Infection (1930); Hydrocephalus (3272); Convulsion/Seizure (4406)

Event Date 02/15/2021

Event Type  Injury  

Event Description

Pacetti, m., giacomini, t., cossu, m., lo russo, g., prato, g., morana, g., tortora, d., d¿orio, p., lodi, m., casellato, s., scarpa, p., cama, a., tassi, l., mancardi, m.M., nobili, l., consales, a.Hemispheric surgery for severe epilepsy in early childhood: a case series.Epileptic disorder.2021; 23 (4): 611-622 doi:10.1684/epd.2021.1303 objective.Hemispheric surgery is an effective and cost-effective option for hemispheric epilepsy.Data specifically focusing on very early infancy are scant.In our study, we report the results of hemispheric surgery in children under three years of age, along with clinical, neuroradiological and eeg features, from two italian epilepsy surgery centres.Methods.After reviewing our epilepsy surgery databases (2008-2018), we identified 14 patients (seven males) submitted to hemispheric surgery, under three years (range: 2-29 months), with a follow-up of at least 12 months.Results.No deaths occurred, and surgical complications were observed in 3/17 procedures.At final follow-up visit (mean: 30.8 months; range: 12-90), 10/14 patients (71.4%) achieved engel class i (eight class 1a, one class 1b, and one class 1c).Antiepileptic drugs were completely discontinued in three and reduced in eight, thus a significant decrease in drug regimen after surgery was achieved in 11/14 patients (78.6%).Before surgery, severe developmental delay was present in 10 patients, moderate in two and mild in two.At the last follow-up visit, the degree of developmental delay changed from severe to moderate in five patients, remained unchanged in six cases (four severe and two moderate), and changed from mild to moderate in two following surgery.Significance.In many cases, hemispheric surgery in children under three years is effective in achieving seizure freedom or reducing seizure frequency, with the possibility of simplifying complex drug regimens.Moreover, it appears to be a safe and well tolerated procedure, leading to improvement in cognition and posture.Reported events three patients were operated on twice.Two patients presented with acute hydrocephalus, which cleared after placement of a temporary external csf (cerebrospinal fluid) shunt in one and ventriculo-peritoneal shunt in the other.One child (patient 6) had a haemorrhagic complication followed by infection after a first surgical approach with lateral peri-insular hemispherotomy; after ventriculo-peritoneal shunting for secondary ventricle dilatation, a second approach with anatomical hemispherectomy was performed without complications.Two patients suffered with acute post-operative seizures (patients 7 and 9), in one case associated with diabetes insipidus which regressed after appropriate medical treatment.

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 accepted date of the literature article.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.

• 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: 12863651
• MDR Text Key: 285834865
• Report Number: 1723170-2021-02746
• 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: 11/23/2021

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: 11/19/2021
• Initial Date FDA Received: 11/23/2021
• 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: 15 MO
• Patient Sex: Male