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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889); Hiccups (1899); Unspecified Infection (1930); Urinary Tract Infection (2120)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Zhu hongyu, zhai xiaodong, meng wenbo, cheng yuefei, yin shangjiong, zhao peilin, wang hongsheng. Stereotactic minimally invasive surgical treatment for hypertensive cerebellar hemorrhage. Chin j neurotrauma surg 3 (2017). Doi: 10. 3877/cma. J. Issn. 2095-9141. 2017. 03. 005. Abstract objective to investigate the therapeutic effect of ct-guided stereotactic minimal invasive and drainage for hypertensive cerebellar hemorrhage. Methods twenty-three cases of hypertensive cerebellar hemorrhage patients treated with stereotactic minimally invasive drainage were retrospectively analyzed in our hospital from january 2013 to june 2016, compared the efficacy with the other 23 patients who underwent posterior fossa craniotomy with hematoma removal at the same time period. The amount of bleeding of two groups were both 10~20 ml. The stereostatic group was given ct guided stereotactic minimal invasive and drainage treatment, after operation, poured urokinase into the hematoma to dissolved it. The craniotomy group was performed posterior cranial fossa craniotomy after general anesthesia and the hemotoma was removaled by the microsurgery, after operation, the hemostasis, dehydration etc were given to the patients. Results the average hospitalization days of the stereostatic group was significantly shorter than the craniotomy group (p
=
0. 01). The postoperative complication of the stereostatic group less than the craniotomy group (p
=
0. 03). The emptying time of hematoma of the stereostatic group langer than the craniotomy group (p
=
0. 04). The activities of daily living classification after six months treatment of the stereostatic group no statistical difference with the craniotomy group (p
=
0. 33). Conclusion the stereotactic minimal invasive and drainage for cerebellar hemorrhage could achieve considerable reset effect compare with the posterior cranial fossa craniotomy, and it was accurate positioning, little injury, less complication, shorter hospitalization and so on. The ster eotactic minimal invasive and drainage for hypertensive cerebellar hemorrhage is worthy for the clinical popularization and application. Reported events. Rebleeding occurred in 4. 35% of patients in both groups. In the stereotactic group (those who used medtronic edm), rebleeding was determined as observing on postoperative ct a larger hematoma volume than the volume of the original hematoma minus the amount that was drained. Other complications occurred at a rate of 8. 69% in the stereotactic group and 34. 78% in the control group. The authors state that ¿postoperative complications were primarily pulmonary infection, upper digestive tract bleeding, urinary tract infection, and persistent hiccup¿.
 
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Brand NameUNKNOWN CATHETER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key9331215
MDR Text Key166937763
Report Number2021898-2019-00413
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN-C
Device Catalogue NumberUNKNOWN-C
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 Received11/07/2019
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: 11/15/2019 Patient Sequence Number: 1
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