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 Paresis (1998); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 09/12/2021

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient sex not available from the site.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and is 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

Di bonaventura, r., montano, n., giordano, m., gessi, m., gaudino, s., izzo, a., mattogno, p.P., stumpo, v., caccavella, v.M., giordano, c., lauretti, l., colosimo, c., giorgio d¿alessandris, q., pallini, r., olivi, a.Reassessing the role of brain tumor biopsy in the era of advanced surgical, molecular, and imaging techniques¿a single-center experience with long-term follow-up.Journal of personalized medicine.2021 (11:9) 1-10.Https://doi.Org/10.3390/ jpm11090909 abstract: brain biopsy is the gold standard in order to establish the diagnosis of unresectable brain tumors.Few studies have investigated the long-term outcomes of biopsy patients.The aim of this single-institution-based study was to assess the concordance between radiological and histopathological diagnoses, and the long-term patient outcome.Ninety-three patients who underwent brain biopsy in the last 5 years were analyzed.We included patients treated with stereotactically guided needle, open, and neuroendoscopic biopsies.Most patients (86%) received needle biopsy.Gliomas and primary brain lymphomas comprised 88.2% of cases.The diagnostic yield was 95.7%.Serious complication and death rates were 3.2% and 2.1%, respectively.The concordance rate between radiological and histological diagnoses was 93%.Notably, the positive predictive value of radiological diagnosis of lymphoma was 100%.Biopsy allowed specific treatment in 72% of cases.Disease-related neurological worsening was the main reason that precluded adjuvant treatment.Adjuvant treatment, in turn, was the strongest prognostic factor, since the median overall survival was 11 months with vs.2 months without treatment (p = 0.0002).Finally, advanced molecular evaluations can be obtained on glioma biopsy specimens to provide integrated diagnoses and individually tailored treatments.We conclude that, despite the huge advances in imaging techniques, biopsy is required when an adjuvant treatment is recommended, particularly in gliomas.Reportable events: post-operative brain edema was recorded in two patients.Post-operative brain edema was recorded in a patients, resulting in hemiparesis.Seizures were recorded in two cases.Pulmonary embolism in three patients.One patient underwent two biopsies.

• 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: 13061023
• MDR Text Key: 287113730
• Report Number: 1723170-2021-02945
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: 12/15/2021
• 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
• Patient Age: 64 YR