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

Model Number UNK_NAV_SYS

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

Patient Problems Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Seizures (2063)

Event Date 10/20/2019

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 accepted date of the publication.Device lot number, or serial number, unavailable.510(k) is unavailable as the value is dependent on the model number of the product.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Citation: soumya mukherjee, joseph wood, imran liaquat, simon r.Stapleton, andrew j.Martin.Craniotomy for recurrent glioblastoma: is it justified? a comparative cohort study with outcomes over 10 years.Clinical neurology and neurosurgery 188 (2020) 105568.Https://doi.Org/10.1016/j.Clineuro.2019.105568.Abstract: objective: the role of repeat resection for recurrent glioblastoma multiforme (rgbm) is unclear.This large comparative cohort study assessed overall survival (os), survival since recurrence (ssr), quality of life, and complications in reoperated versus non-reoperated patients for rgbm.Patients and methods: all patients with rgbm between 2005 and 2015, who were discussed by our institution¿s multi-disciplinary team, and who either did or did not undergo reoperation, were prospectively followed up with data collected and compared.Survival and prognostic factors were analysed using kaplan¿meier and cox regression methods.Results: 312 patients (reoperated, n=145; non-reoperated, n=167) were analysed.Median ssr was 10.8 months and 6.9 months in the reoperated and non-reoperated groups respectively (log-rank test: p=0.02).Median os was 24.1 months and 20.4 months in the reoperated and non-reoperated groups, respectively (logrank test: p=0.04).Quality of life as measured by short form 36 scores were 59 versus 54 at baseline and 62 versus 51 at four-month follow-up for re-operated and non-reoperated groups, respectively (p < 0.05).Age< (><<)>60 years, karnofsky performance status (kps) = 80, recurrence = 9 months from initial diagnosis, methylguanine methyltransferase (mgmt) promoter methylation, and extent of resection (eor)>80 %, each were significant predictors of ssr and os.Complication rates were 5.5 % and 6.2 % following repeat resection and primary resection, respectively (p > 0.05).Conclusion: this is the first large prospective comparative cohort study of rgbm and demonstrates that repeat resection confers a small but significant benefit in survival and quality of life over non-operative treatment.Best prognosis is associated with: younger age, kps=80, late recurrence, mgmt promoter methylation and eor > 80 %.Reported events: two patients in the non-reoperated cohort experienced worsening neurological deficits.Four patients in the non-reoperated cohort experienced infections.Three patients in the non-reoperated cohort experienced seizures.

• Brand Name: MEDTRONIC NAVIGATION
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 10171217
• MDR Text Key: 197754824
• Report Number: 1723170-2020-01699
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event 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: 06/02/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR