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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Edema (1820); Unspecified Infection (1930); Paresis (1998)
Event Date 02/11/2016
Event Type  Injury  
Manufacturer Narrative
Date of death is not known. Therefore, date of publication was used. There is no allegation that the device malfunctioned or caused the patient hemiparesis or postoperative morbidity. Therefore, no testing will be performed. Device functioned properly. No parts replaced or returned. Hamamcioglu, m. K. , akcakaya, m. O. , goker, b. , kasimcan, m. O. , kiris, t. (2016). The use of the yellow 560 nm surgical microscope filter for sodium fluorescein-guided resection of brain tumors: our preliminary results in a series of 28 patients. Clinical neurology and neurosurgery (143), 39¿45. Retrieved from www. Elsevier. Com/locate/clineuro.
 
Event Description
Per attached journal article, twenty-eight consecutive patients (15 female and 13 male,mean age 53. 9 years, range 6 to 78 years) with suspected and newly diagnosed high-grade and metastatic tumors (based on the mri and clinical findings) underwent na-fl-guided surgery between january and november 2015. All patients with suspicious high-grade gliomas and singular or multiple solitary cerebral metastatic lesions were included. A total of 30 surgeries were performed. Patients with renal or hepatic insufficiency or with a known allergy to na-fl were excluded from the study. Patients were evaluated with preoperative cranial magnetic resonance imaging (mri) with and with-out contrast. Mri-neuronavigation (stealthstation s7 system, medtronic, (b)(4), usa) was used in all instances intraoperatively for craniotomy planning and tumor localization, and in a manner to prevent postoperative morbidity. No side effects or adverse reactions were encountered due to the intravenous use of na-fl in this series. There were no permanent new neurological deficits post-operatively. The only complications were a transient hemiparesis in two patients, which was attributed to edema. Four patients (14. 3%) died during the follow-up period due to pulmonary embolism, pulmonary infection, sepsis as a chemotherapy complication and unknown cause. There was no evidence of tumor progression during the relatively short follow-up period in other patients. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
catherine eaton
826 coal creek circle
louisville, CO 80027
7208902092
MDR Report Key5648069
MDR Text Key44987868
Report Number1723170-2016-00816
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/11/2016 Patient Sequence Number: 1
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