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); Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 11/10/2017

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 accepted date of the publication.Device lot number, or serial number, unavailable.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.

Event Description

Citation: anan shtaya, joy roach, ahmed-ramadan sadek, benjamin gaastra, jonathan hempenstall, and diederik bulters.Image guidance and improved accuracy of external ventricular drain tip position particularly in patients with small ventricles.J neurosurgery, 130:1268-1273, 2019 objective external ventricular drain (evd) insertion is one of the most common emergency neurosurgical procedures.Evds are traditionally inserted freehand (fh) in an emergency setting, but often result in suboptimal positioning.Image-guided surgery (igs) is selectively used to assist placement.However, the accuracy and practicality of igs use is yet to be reported.In this study, the authors set out to assess if igs is practical and improves the accuracy of evd placement.Methods case notes and images obtained in patients who underwent frontal evd placement were retrospectively reviewed.Ventriculomegaly was determined by the measurement of the evans index.Evd location was classified as optimal (ipsilateral frontal horn) or suboptimal (any other location).Propensity score matching of the two groups (igs vs fh) for the evans index was performed.Data were analyzed for patient age, diagnosis, number of evds, and complications.Those without postoperative ct scans were excluded.Results a total of 607 patients with 760 evds placed were identified; 331 met inclusion criteria.Of these, 287 were inserted fh, and 44 were placed with igs; 60.6% of all unmatched fh evds were optimal compared with 75% of the igs group (p = 0.067).The igs group had a significantly smaller evans index (p <(><<)> 0.0001).Propensity score matching demonstrated improved optimal position in the igs group when compared with the matched fh group (75% vs 43.2%, or 4.6 [1.5¿14.6]; p = 0.002).Patients with an evans index of = 0.36 derived less benefit (75% in igs vs 66% in fh, p = 0.5), and those with an evans index <(><<)> 0.36 derived more benefit (75% in igs vs 53% in fh, p = 0.024).The overall evd complication rate was 36% in the fh group versus 18% in the igs group (p = 0.056).Revision rates were higher in the fh group (p = 0.035), and the operative times were similar (p = 0.69).Long intracranial evd catheters were associated with tip malposition irrespective of the group.Conclusions image guidance is practical and improves the accuracy of evd placement in patients with small ventricles; thus, it should be considered for these patients.Reported events: 5 instances of infection were noted.1 instance of the catheter falling out was noted.1 instance of a cerebrospinal fluid (csf) leakage was noted.1 blockage of the catheter was noted.3 instanced of evd revision/reinsertion was noted.Additional information was received.It was reported that there were no issues with medtronic products.

• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11049853
• MDR Text Key: 226789483
• Report Number: 1723170-2020-03367
• 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: Physician
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 12/04/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR