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 Problem Intracranial Hemorrhage (1891)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: unk_nav_comp, serial/lot #: unknown unk_nav_comp represents the channel.Patient information was not included in the journal entry.This value reflects the median age of the patients who underwent the etv and/or endoscopic cyst fenestration as specific patients could not be identified.This value reflects the majority gender of the patients who underwent the etv and/or endoscopic cyst fenestration as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the published online 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

Acta neurochirurgica (2020) 162:2975¿2982 https://doi.Org/10.1007/s00701-020-04419-1 summary object: the purpose of this study was to evaluate whether endoscopic third ventriculostomy (etv) and endoscopic cyst fenestration are effective minimally invasive alternatives to a craniotomy with cyst resection for the treatment of symptomatic pineal cyst-associated aqueductal stenosis.Methods: sixteen patients with symptomatic pineal cysts were operatively managed endoscopically and these cases were retrospectively reviewed.There were 12 females and 4 males.The median age at the time of surgery was 31 years (range 3 to 62 years).Results: all patients presented with symptoms and imaging consistent with elevated intracranial pressure.The median maximum cyst diameter was 15mm(range 10mmto 27mm).In all cases, there was mass effect on the tectum that resulted in effacement of the cerebral aqueduct and ventriculomegaly was present in 38% of cases.Etv was performed in 15 patients.Cyst fenestration was performed in 2 patients, one of which also had an etv.Resolution of symptoms was achieved in 81% of patients with a median follow-up of 13 months.Conclusion: this study showed that etv is effective for symptomatic pineal cyst-associated aqueductal stenosis.Patients can be symptomatic without overt ventriculomegaly and normal ventricular volume does not preclude safe endoscopic management.Endoscopic cyst fenestration is recommended if a perinaud syndrome is present or if etv is not feasible.Reported events: sixteen patients with a histology of pineal cyst-associated aqueductal stenosis underwent etv and/or cyst fenestration.Among these patients, nine patients had trace intraopertative bleeding from the tuber cinereum following the etv.The complication was resolved with irrigation alone.One patient that had pineal cyst fenestration had slight bleeding from the edge of the pineal cyst fenestration, which ceased spontaneously.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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12585803
• MDR Text Key: 275143898
• Report Number: 1723170-2021-02446
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• 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: 09/21/2021
• 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: 31 YR