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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Erosion (1750); Death (1802); Hematoma (1884); Hemorrhage, Subdural (1894); Septic Shock (2068)
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Matheus fernandes de oliveira, felippe saad, rodolfo casimiro reis, josé marcus rotta, fernando campos gomes pinto. Programmable valve represents an efficient and safe tool in the treatment of idiopathic normal-pressure hydrocephalus patients. Arq neuropsiquiatr 71 (2013). Doi: 10. 1590/0004-282x20130007 abstract idiopathic normal pressure hydrocephalus (inph) is characterized by gait disturbance, dementia and /or urinary incontinence, dilation of the ventricular system and normal opening cerebrospinal fluid pressure. Shunt surgery is the standard treatment of inhp. Diversions with programmable valves are recommended, once drainage pressure can be changed. However, well-defined protocols still lack guiding the steps to attain proper pressure for each patient. Methods: in our study, we reported the experience of shunting 24 patients with inph using strata® (medtronic) valve, following a protocol based on a positive tap test. Results: we observed clinical improvement in 20 patients and stability/ worsening in 4 patients. Complications occurred in five patients, including one death. The results display improvement, and complications occurred at a lower rate than reported in other studies. Conclusions: the strata® valve used in the proposed protocol represents an efficient and safe tool in the treatment of inph. - there were eight complications in five patients (three males and two females). In the follow-up, malfunctioning of the valve forced the valve revision in two patients. One patient presented wound dehiscence and valve exposure after six months of the surgery, and it was necessary to remove the valve. There was no significant difference in complications rate between males and females (p < 0. 01). Subdural collections occurred in four patients. One of them developed subdural collection after ongoing mri examination and having the valve pressure reset. Initially, all collections were subdural hematomas, two managed conservatively with valve adjustment and two with surgical treatment. The decision was made considering the patient clinical presentation, location and volume of the hematoma. The asymptomatic/oligosymptomatic patients had their valves adjusted and were followed with resolution of the hematomas. The symptomatic patients or those with large collections were managed aggressively with surgical drainage. The management of subdural hematomas with valve adjustment consisted of resetting the level to 2. 5 and weekly follow-up until recovery from symptoms and absorption of the hematoma. After that, the patient began again the quarterly adjustment towards the best level without new complications. Fortunately, shunt infections did not occur in our sample. However, in one case, the subdural hematoma recurred after the first drainage, and after the second drainage there was progression to subdural empyema. This patient died from septic shock.
 
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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 Key10589893
MDR Text Key208705309
Report Number2021898-2020-00245
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeBR
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 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received09/08/2020
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: 09/25/2020 Patient Sequence Number: 1
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