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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UKNOWN SEPS KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UKNOWN SEPS KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Intracranial Hemorrhage (1891); Pneumonia (2011); Urinary Tract Infection (2120); Convulsion/Seizure (4406); Thrombosis/Thrombus (4440)
Event Date 04/24/2021
Event Type  Injury  
Event Description
Austin carpenter, mitchell rock, ehsan dowlati, charles miller, jeffrey c. Mai, ai-hsi liu, rocco a. Armonda, daniel r. Felbaum. Middle meningeal artery embolization with subdural evacuating port system for primary management of chronic subdural hematomas. Neurosurgical review (2021). Doi: 10. 1007/s10143-021-01553-x abstract optimal treatment for chronic subdural hematomas remains controversial and perioperative risks and comorbidities may affect management strategies. Minimally invasive procedures are emerging as alternatives to the standard operative treatments. We evaluate our experience with middle meningeal artery (mma) embolization combined with subdural evacuating port system (seps) placement as a first-line treatment for patients with csdh. A single institution retrospective review was performed of all patients undergoing intervention. Patients were stratified by treatment with mma embolization and seps placement, mma embolization and surgery, seps placement only, and surgery only for csdh from 2017 to 2020, and cohorts were compared against each other. Patients treated with mma/seps were more likely to be older, be on anticoagulation, have significant comorbidities, have shorter length of stay, and less likely to have symptomatic recurrence compared to seps only cohort. Thus, mma/seps appears to be a safe and equally effective minimally invasive treatment for csdh patients with significant comorbidities who are poor surgical candidates. Reported events. - complications for the mma embolization + seps were 4 seizures, 1 urinary tract infection, 2 acute kidney injury, 1 pneumonia, and 1 dvt/pe (deep venous thrombosis/ pulmonary embolism). Complications for seps only were 2 seizures, 2 urinary track infections, and 1 pneumonia. 60-day recurrence requiring re-operation for the mma embolization + seps included 2 patients. 60-day recurrence requiring re-operation for the seps only included 7 patients.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameUKNOWN SEPS KIT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12558461
MDR Text Key280939183
Report Number2021898-2021-00171
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1
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