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 Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Paralysis (1997); Unspecified Nervous System Problem (4426)

Event Date 10/25/2021

Event Type  Injury  

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 online publication date of the literature article.Device lot number, or serial number, unavailable.Pma/510(k) is dependent upon the device model number, therefore is 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: chiman jeon, jung won choi, doo-sik kong, do-hyun nam, jung-il lee, ho jun seol.Treatment strategy for giant solid hemangioblastomas in the posterior fossa: a retrospective review of 13 consecutive cases.World neurosurg.(2022) 158:e214-e224.Https://doi.Org/10.1016/j.Wneu.2021.10.169 abstract: objective: to analyze radiologic characteristics, treatment strategy, and treatment outcomes of posterior fossa giant solid hemangioblastomas (gshbs; ¿4 cm in maximum diameter).Methods: we performed a retrospective study of 13 consecutive patients (9 male and 4 female patients; mean age, 57.5 13.3 years; range, 24e76 years) with gshb who underwent surgical resection at a single institution between 2002 and 2018.The median follow-up was 33 months (range, 12e120 months).For each patient, neuroimaging findings, operative record, and treatment outcome were reviewed.Results: seven tumors (53.8%) were located within cerebellar hemispheres, 4 (30.8%) in proximity to the brainstem, 1 (7.7%) within the cerebellar vermis, and 1 (7.7%) in the cerebellopontine angle.The mean maximum diameter was 4.8 0.8 cm (range, 4.0e6.7 cm).Gross total resection was achieved in 11 patients (84.6%), and near total resection in 2 patients (15.4%).Surgical complications occurred in 5 patients (38.5%); persistent neurologic deficits occurred in 2 patients (15.4%).Estimated progression-free survival after surgery was 92.3%, 80.8%, and 80.8% at 1, 5, and 10 years, respectively, whereas the estimated 1-year, 5-year, and 10-year overall survival was 100%, 90%, and 90%, respectively.Conclusions: gshbs are surgically challenging.The current study shows that favorable outcome can be achieved for gshbs in the cerebellar hemispheres and vermis.For those involving the brainstem, planned near-total resection or subtotal resection in a piecemeal fashion can be attempted if en bloc resection is judged to be infeasible, and further intervention can be considered as needed.Reported events: 1) two patients experienced transient lcn palsy after the procedure 2) a patient experienced a cerebrospinal fluid (csf) leak with wound infection that required revision surgery and intravenous autobiotic therapy.3) one patient experienced transient abducens nerve palsy 4) two patients experienced neurological deficits that required a tracheostomy and percutaneous endoscopic gastrostomy.

• 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: 14592614
• MDR Text Key: 293271724
• Report Number: 1723170-2022-00849
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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: 05/13/2022
• 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: 57 YR
• Patient Sex: Male