MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7; INSTRUMENT, STEREOTAXIC

Model Number 9733858

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)

Event Date 12/20/2020

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.The unique identifier was not known at the time of reporting.Date of event: please note that this date is based off of the date when the article was accepted for publication as the event dates were not provided in the published literature.No parts have been received by the manufacturer for evaluation.The manufacture date was not known at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Hall, s., kabwama, s., sadek, a.R., dando, a., roach, j., weidmann, c., grundy, p., awake craniotomy for tumour resection: the safety and feasibility of a simple technique.Interdisciplinary neurosurgery: advanced techniques and case management.2021 24 (1-6).Ht tps://doi.Org/10.1016/j.Inat.2020.101070 introduction: awake craniotomy is widely used for surgery in eloquent brain in order to facilitate maximal safe resection of brain tumours.There has been huge progress in both surgical and anaesthetic techniques used during awake craniotomy.This study reports a single surgeon experience of awake craniotomy for tumour resection over a 14 year period focusing on the safety and feasibility of a simple technique.Methods: patients who underwent awake craniotomy for tumour resection between 2006 and 2019 (inclusive) were identified retrospectively from theatre logbooks in an nhs neurosciences centre.Case note review was performed to collect data on demographics, histology, intra-operative mapping and complications.Results: four hundred and sixty-nine patients were included with a mean age of 52.0 ± 14.3 years.Three hundred and seventy-seven (80.2%) of the tumours were primary tumours of which who grade iv were the most common (n = 204, 54.1%).Ninety-two (19.6%) of the tumours were metastases with breast (n = 23, 25.0%), skin (n = 22, 23.91%) and lung (n = 22, 23.9%) being the most common primary malignancies.The frontal lobe was the most common location (n = 221, 47.1%).The median length of stay was 1 day.One hundred and seven (22.8%) patients had complications with neurological deficits (n = 73, 15.6%), being the most common however only 8 patients (1.7%) had permanent neurological deficits.Discussion: this is the largest published uk series of awake craniotomy for tumour resection.It demonstrates the safety and feasibility of a simple and easily reproducible technique with a low incidence of permanent neurological deficits and short durations of hospital admission.Reported events of the 175 patients who remained in hospital longer than one day post-operatively 54 had a documented complication requiring treatment or observation.114 complications were recorded for 107 (22.8%) patients.73 neurological deficits were reported and found to be the most common complication 8 patients were left with a permanent new neurological deficit 4 patients had a vascular aetiology (stroke) 1 patient had severe brain swelling intra-operatively 1 patient had rapidly progressive weakness due to eloquently placed tumour remnant 1 patient suffered expressive dysphasia in a tumour biopsied because it was all positively mapped 1 patient with a tumour in eloquent cortex all of which mapped positive but the patient elected to proceed with tumour resection regardless, accepting the morbidity.28 patients had significant seizures which was the second most common complication 5 patients developing new post-operative seizures 1 patient had major seizures that prevented further surgery and required general anesthesia 5 patients had post-operative haemorrhage requiring a return to theatre for evacuation of the haematoma 3 patients had an infected bone flap 2 patient had a cerebrospinal fluid leak 2 patients had hydrocephalus/pseudomeningocoele requiring a ventriculoperitoneal shunt 1 patient had a deep vein thrombosis 1 patient did not tolerate an awake procedure and had their procedure abandoned after taking a biopsy only as it wasn't safe to proceed due to highly eloquent tumour location 4 patients had their procedure aborted after a biopsy only because the entire area of brain involved with tumour had positive mapping.

• Brand Name: STEALTHSTATION S7
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11630949
• MDR Text Key: 245107401
• Report Number: 1723170-2021-00918
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2021
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 52 YR