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 Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Inflammation (1932); Renal Failure (2041); Urinary Tract Infection (2120); Convulsion/Seizure (4406)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: u nk_nav_comp, serial/lot #: unk unk_nav_comp represents the axiem stylet.Patient information was not included in the journal entry this value reflects the average age of the patients who underwent the mis procedure as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the mis procedure as specific patients could not be identified.The event date was not provided in the article.The date provided is the published date.The article citation is included.The system product number and serial number were not provided in the journal article.Udi not available for this system.The instrument product number and lot number were not provided in the journal article.Udi not available for this instrument.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

World neurosurg.(2021) 149:e592-e599.Https://doi.Org/10.1016/j.Wneu.2021.01.128 summary background: intracerebral hemorrhage (ich) is the most devastating form of stroke, with thalamic hemorrhages carrying the worst outcomes.Minimally invasive (mis) endoscopic ich evacuation is a promising new therapy for the condition.However, it remains unclear whether therapy success is location dependent.Here we present long-term functional outcomes after mis evacuation of spontaneous thalamic hemorrhages.Methods: patients presenting to a single urban health system with spontaneous ich were triaged to a central hospital for management of ich.Operative criteria for mis evacuation included hemorrhage volume ¿15 ml, age ¿18, national institutes of health stroke scale ¿6, and baseline modified rankin score (mrs) £3.Demographic, radiographic, and clinical data were collected prospectively, and descriptive statistics were performed retrospectively.Functional outcomes were assessed using 6-month mrs scores.Results: endoscopic ich evacuation was performed on 21 patients.Eleven patients had hemorrhage confined to the thalamus, whereas 10 patients had hemorrhages in the thalamus and surrounding structures.Eighteen patients (85.7%) had intraventricular extension.The average preoperative volume was 39.8 ml (standard deviation [sd]: 31.5 ml) and postoperative volume was 3.8 ml (sd: 6.1 ml), resulting in an average evacuation rate of 91.4% (sd: 11.1%).One month after hemorrhage, 2 patients (9.5%) had expired and all other patients remained functionally dependent (90.5%).At 6-month follow-up, 4 patients (19.0%) had improved to a favorable outcome (mrs £ 3).Conclusion: among patients with ich undergoing medical management, those with thalamic hemorrhages have especially poor outcomes.This study suggests that mis evacuation can be safely performed in a thalamic population.It also presents long-term functional outcomes that can aid in planning randomization schemes or subgroup analyses in future mis evacuation clinical trials.Reported events: twelve patients with a histology of ich underwent a mis endoscopic ich evacuation.There were medical complications that included ten cases of pneumonia, two cases of ventriculitis, two cases of gastrointestestinal bleeding, two cases of acute kidney injury, one case of seizure, and readmission for urinary tract infections sepsis.See attached article.

• 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: 12579460
• MDR Text Key: 274920287
• Report Number: 1723170-2021-02437
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2021

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: 09/20/2021
• Initial Date FDA Received: 10/05/2021
• 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; Required Intervention
• Patient Age: 61 YR