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

Model Number UNK_NAV_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Muscle Weakness (1967); Unspecified Tissue Injury (4559)

Event Date 06/09/2019

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of the patients who experienced adverse events in the study.Patient gender was the majority value of patients in the study who experienced adverse events in the study.Patient weight not available from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: jonathan parish, matthew mcpheeters, scott d.Wait.Endoscopic management of benign cystic lesions of the thalamus with fenestrated stent placement.Journal of clinical neuroscience 67 (2019) 226-230.Https://doi.Org/10.1016/j.Jocn.2019.06.028 abstract: benign intracranial cystic lesions of the thalamus are an uncommon clinical entity rarely requiring operative decompression.In combination with cyst fenestration, cerebrospinal fluid (csf) flow diversion or fenestrated stent placement may be performed at the time of surgery.We describe a method of treatment of these cysts using endoscopic cyst fenestration with fenestrated transventricular stent placement.Three patients with benign cystic lesions were treated with stereotactic-guided, endoscopic fenestration and fenestrated stent placement.All 3 had radiographic and clinical improvement.There were no complications.Endoscopic fenestration and transventricular fenestrated stent placement is a minimally invasive, effective, and safe method to decompress benign, symptomatic cystic lesions of the thalamus.Reported events: (b)(6) male experienced a mild headache and progressive left sided weaknessat four months post-operative.The patient subsequently underwent an additional fenestration and fenestrated stent placement which resolved the symptoms.(b)(6) male experienced displacement of their stent.The patient underwent a redo cyst fenestration and third ventriculostomy.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11047854
• MDR Text Key: 226797202
• Report Number: 1723170-2020-03359
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 12/08/2020
• 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): Required Intervention
• Patient Age: 20 YR