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 Bacterial Infection (1735); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Pleural Effusion (2010); Renal Failure (2041)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.Patient gender is the majority value of patients in the study.Patient weight not available from the site.Event date is the online publish date of the publication.Device lot number, or serial number, unavailable.510(k) is dependent upon field d4 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

Citation: alon orlev, gil kimchi, liat oxman, idan levitan, david felzenstein, nentanel ben shalom, shani berkowitz, ido ben zvi, yosek laviv, giorgio rubin, uzi ben david, sagi harnof.Minimally invasive intracerebral hematoma evacuation using a novel cost-effective tubular retractor: single-center experience.World neurosurg.(2021) 150:42-53.Https://doi.Org/10.1016/j.Wneu.2021.03.083 background: spontaneous intracerebral hematoma (ich) is a common disease with a dismal overall prognosis.Recent development of minimally invasive ich evacuation techniques has shown promising results.Commercially available tubular retractors are commonly used for minimally invasive ich evacuation yet are globally unavailable.Methods: a novel u.S.$7 cost-effective, off-the-shelf, atraumatic tubular retractor for minimally invasive intracranial surgery is described.Patients with acute spontaneous ich underwent microsurgical tubular retractoreassisted minimally invasive ich evacuation using the novel retractor.Patient outcome was retrospectively analyzed and compared with open surgery and with commercial tubular retractors.Results: ten adult patients with spontaneous supratentoria ich and median preoperative glasgow coma scale score of 10 were included.Ich involved the frontal lobe, parietal lobe, occipitotemporal region, and solely basal ganglia in 3, 3, 2, and 2 patients, respectively.Mean preoperative ich volume was 80 ml.Mean residual hematoma volume was 8.7 ml and mean volumetric hematoma reduction was 91% (median, 94%).Seven patients (70%) underwent >90% volumetric hematoma reduction.The total median length of hospitalization was 26 days.On discharge, the median glasgow coma scale score was 12.5 (mean, 11.7).Thirty to 90 days' follow-up data were available for 9 patients (90%).The mean follow-up modified rankin scale score was 3.7 and 5 patients (56%) had a modified rankin scale score of 3.Conclusions: the novel cost-effective tubular retractor and microsurgical technique offer a safe and effective method for minimally invasive ich evacuation.Cost-effective tubular retractors may continue to present a valid alternative to commercial tubular retractors.Reported events: 1) 72 year old patient experienced a second spontaneous ich anatomically unrelated and it was noted that the ich resolved spontaneo usly 2) 76 year old patient experienced a subdural effusion with no mass effect that was noted to resolve spontaneously 3) 60 year old patient experienced seizures and vap that were resolved with tx 4) 44 year old patient experienced a cns infection that was resolved withtx 5) 68 year old patient experienced a cns infection that was resolved with tx 6) 48 year old patient experienced renal failure, cap and seizures that were resolved with tx 7) 42 year old patient experienced a cns infection that was resolved with tx 8) 71 year old patient experienced a suspected infected cerebral fluid collection that underwent subsequent debridement.

• 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: 12617202
• MDR Text Key: 276408416
• Report Number: 1723170-2021-02484
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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: 09/20/2021
• 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
• Patient Age: 62 YR