• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735665
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seroma (2069)
Event Date 04/11/2022
Event Type  Injury  
Manufacturer Narrative
Patient age not available from the site.A 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.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: pietro spennato, andrea de rosa, giulia meccariello, lucia quaglietta, alessia imperato, maria rosaria scala, carmela russo, giuseppe cinalli.Endoscopic ultrasonic aspiration as alternative to more invasive surgery in initial management of optic pathway gliomas in children.Abstract: introduction: optic pathway gliomas (opgs) presenting with acute hydrocephalus represent a true neurosurgical and neurooncological c hallenge.Two main strategies are currently used: microsurgical removal of the tumor, restoring csf pathways, and endoscopic biopsy associated with ventriculo-peritoneal shunt implantation.Since the availability of an ultrasonic aspirator handpiece, that can be used inside the working channel of a neuroendoscope, a different less invasive surgical strategy can be used.Methods: four pediatric patients were treated by endoscopic ultrasonic aspiration, in order to remove the upper pole of the tumor, obtaining tissue for diagnosis and restoring csf pathways as initial treatment of opg invading the third ventricle and causing hydrocephalus due to simultaneous blockage of both monro foramina and of the sylvian aqueduct.Surgical technique is described.Pre-operative and post-operative volumes were calculated on magnetic resonance imaging.Results: in all cases, the surgical procedure was uneventful, the biopsy was diagnostic, and csf pathways were restored.The amount of tumor removed ranged between 31 and 76%.All patients underwent oncological treatment of their tumors.One patient received v-p shunt only 1 year after endoscopic decompression due to tumor progression.Conclusion our preliminary results show that the use of endoscopic cavitron aspirator is safe and effective to obtain csf flow restoration and tumor biopsy (for histological and molecular purposes), avoiding csf shunt implant in the acute phase and offering the chance to obtain a consistent tumor debulking in a minimally invasive fashion.Neuroendoscopic approach together with modern target therapy offers the opportunity to avoid or delay major surgery.Reported event: one patient developed a subdural hygroma that necessitated transient subduro-peritoneal shunting.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STEALTHSTATION¿ S8 SYSTEM
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 Key14348026
MDR Text Key291315716
Report Number1723170-2022-00715
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/06/2022
Initial Date FDA Received05/10/2022
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 Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
-
-