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

Model Number UNK_NAV_SYS

Device Problem Imprecision (1307)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model/part number, 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

Citation: federico frio, domenico solari, luigi maria cavallo, paolo cappabianca, gérald raverot, emmaluel jouanneau.Ommaya resevoir system for the treatment of cystic craniopharyngiomas: surgical results in a series of 11 adult patients and review of the literature.World neurosurgery.Https://doi.Org/10.1016/j.Wneu.2019.07.217 abstract: objectives: treatment of cystic craniopharyngiomas can be challenging and recurrences are frequent, even after total resection.In selected cases, less aggressive surgery with the sole drainage of the cyst reliefs symptoms caused by mass effect and represents a valid alternative option, notably in pediatric population.We herein analyze a series of adult cystic craniopharyngiomas, managed with ommaya reservoir implant, focusing on local tumor control and eventual complications.Methods: 11 non-consecutive adult cystic craniopharyngiomas (7 recurrent lesions) have been treated with ommaya reservoir system (ors), in two neurosurgical centers.Ors was placed in nine cases using minimally invasive procedures: six burr hole endoscopic insertion and three navigated electromagnetic placement; in the remaining two patients, the ommaya reservoir was used as a shunt to prevent cyst recollection during a transcranial approach.Results: the main presenting symptoms were visual impairment (75%), cognitive and behavioral disorders (66.7%), hypopituitarism (38%), headache (30.8%) and hypothalamic obesity (8%).The median follow-up period was 41.4 months.In all patients the visual function and intracranial hypertension improved after decompression.Local tumor control was accomplished in eight patients (72.7%), without the need of adjuvant treatments.The endoscopic vision carried similar rates of tumor control than stereotaxy (75% vs 66.7%).Conclusions: in selected patients, tailored procedures are required to achieve long-term tumor control and as well limit surgery-related morbidity.Ors could represent a safe and effective treatment option for cystic craniopharyngiomas, providing also reduced surgical related morbidity especially in recurrent lesions and in patients non suitable for radical surgery.Reported events: one patient experienced an ommaya infection two weeks after the neuroendoscopic placement which required system removal.One instance of stereotactic catheter malpositioning, which required a stereotactic replacement.One patient experienced a cerebrospinal fluid (csf) leakage around the subcutaneous reservoir that was derived with a meningo-peritoneal shunt.

• 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: 12642065
• MDR Text Key: 277859426
• Report Number: 1723170-2021-02517
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 09/22/2021
• 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): Required Intervention