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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894); Paresis (1998); Therapeutic Response, Decreased (2271)
Event Date 04/11/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Tze-wei chang, pao-hui tseng, yi-cheng wang, guo-fang tseng, tsung-lang chiu, shinn-zong lin and sheng-tzung tsai. Dopaminergic degeneration and small vessel disease in patients with normal pressure hydrocephalus who underwent shunt surgery. Journal of clinical medicine 9 (2020). Doi:10. 3390/jcm9041084. Abstract: the diagnosis of idiopathic normal pressure hydrocephalus (inph) and the outcome of lumboperitoneal shunt treatment remains to be systematically explored. Here, we aim to evaluate whether the severity of dopaminergic degeneration and white matter small vessel disease could be predictors of outcome for inph patients subjected to lumboperitoneal shunt treatment. This is a single center retrospective study with 39 patients with probable inph undergoing programmable surgical lumboperitoneal shunt from june 2016 to march 2018 at hualien tzu chi hospital. In all patients, dopaminergic degeneration was determined with 99mtc- trodat-1 spect scan, while white matter small vessel disease (fazekas scale) was assessed with brain mri. The inph grading scale (inphgs) score and karnofsky performance score (kps) pre- and post-operation (6-month follow-up) were available for all patients. Linear regression was used to correlate the severities of dopaminergic degeneration and small vessel disease with lumboperitoneal shunt treatment outcomes. Their inphgs score improved significantly after surgery (pre-operatively, 7. 8 2. 6; post-operatively, 5. 7 2. 6 (26. 9% improvement) (p <(><<)> 0. 05)). Moreover, the kps was also improved significantly after surgery, by a mean of 24. 6% from the baseline score (p <(><<)> 0. 05). A significant correlation was observed between the severity of dopaminergic degeneration and a poorer improvement of inphgs score (p
=
0. 03). However, improvement of the inphgs score was not correlated with white matter small vessel disease. Dopaminergic degeneration comorbidity neutralized the degree of improvement after surgery. Although white matter small vessel disease was correlated with inph incidence, it may not be a prognostic factor for shunt operation. These findings have implications for the use of dopaminergic imaging, as they might help predict the surgical outcome of patients with inph, while vascular mechanisms seem to be involved in inph pathophysiology. Reported events. - two serious adverse effects related directly to the surgery were reported. One patient developed chronic subdural hematoma requiring drainage surgery about 2 months after shunt placement. His hemiparesis recovered fully after hematoma drainage. Another patient¿s subdural hematoma recovered after we adjusted the pressure setting from level 1. 0 to 2. 0. - one patient exhibited recurrence of the inph symptoms, and shunt tube (intrathecal tube) migration was detected about 2 months after surgery. The patient¿s symptoms improved gradually after we repositioned the lumbar end of the tube.
 
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Brand NameUNKNOWN STRATA VALVE/SHUNT
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10596059
MDR Text Key208851237
Report Number2021898-2020-00247
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeTW
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 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
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 Received09/24/2020
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: 09/28/2020 Patient Sequence Number: 1
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