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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-V
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Infarction, Cerebral (1771); Death (1802); Fatigue (1849); Fever (1858); Headache (1880); Hearing Impairment (1881); Hemorrhage, Subdural (1894); Neurological Deficit/Dysfunction (1982); Paresis (1998); Therapeutic Effects, Unexpected (2099); Visual Disturbances (2140); Chills (2191); Dysphasia (2195); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Cognitive Changes (2551)
Event Date 06/28/2017
Event Type  Death  
Manufacturer Narrative
Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided. Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided. Please note that this date is based off the date of publication of the article as the actual event date was not provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Chih-wei hung, wei-che lin, wen-neng chang, tsung-ming su, chia-te kung, nai-wen tsai, hung-chen wang, chih-cheng huang, ben-chung cheng, yu-jih su, ya-ting chang, chih-min su, sheng-yuan hsiao, cheng-hsien lu. Risk factors and outcomes of cerebrospinal fluid overdrainage in hiv-negative patients with cryptococcal meningitis after the ventriculoperitoneal shunting procedure. Journal of microbiology 51 (2018). Doi: 10. 1016/j. Jmii. 2017. 06. 002 abstract purpose: shunt procedures used to treat cryptococcal meningitis complicated with hydrocephalus and/or increased intracranial pressure (iicp) could result in cerebrospinal fluid (csf) overdrainage, thereby presenting therapeutic challenges. Methods: we analyzed the clinical features and neuroimaging findings after the ventriculoperitoneal (vp) shunt procedure in 51 hiv (human immunodeficiency virus)-negative patients with cryptococcal meningitis, to assess the risk factors associated with post-shunt csf overdrainage. Results: symptomatic csf overdrainage occurred in 12% (6/51) of patients with cryptococcal meningitis who underwent the shunt procedure. Rapid deterioration of neurological conditions was found in 6 patients after the shunt procedure was performed, including disturbed consciousness, quadriparesis, and dysphasia in 5 patients and severe ataxia in 1. The mean duration of csf overdrainage after the shunting procedure was 2-7 days (mean 4 days). The mean interval between meningitis onset to shunting procedure remained independently associated with csf overdrainage, and the cut-off value for predicting csf overdrainage in interval between meningitis onset to shunting procedure was 67. 5 days. Conclusions: csf overdrainage after the vp shunt procedure is not rare, especially in patients with a high-risk of cryptococcal meningitis who also have a prolonged duration of hydrocephalus and/or iicp. Reported events. Among the 51 patients who underwent the shunt procedure, 49 of the patients had a medtronic shunt. 6 out of 6 patients with medtronic shunts experienced overdrainage. 43 out of 45 patient with medtronic shunts experienced no overdrainage. Neurological conditions deteriorated rapidly (within 1 week) in the 6 patients who had csf overdrainage after having undergone the shunting procedure. The clinical features of the patients with csf overdrainage include 4 fever/chills, 5 headache, and 4 disturbed consciousness at emergency room. The neuroimaging findings of patients with csf overdrainage included 1 cerebral infarction, 1 gyral enhancement, 1 basal cistern effacement, 1 pseudo-cyst, and 2 dilated virchow-robin space. Follow-up neuroimaging studies in the 6 patients who had overdrainage after the shunt procedure showed thin-layer subdural effusion in both hemispheres. The symptoms observed in these 6 patients were disturbed consciousness and acute quadriparesis with dysphasia in 5 patients, and severe ataxia in 1. In addition, the effect on ventricular relief on the 6 patients who experienced overdrainage include unsteady gait, drowsiness, and frontoparietal subdural hemorrhage. The time duration between the completion of shunt procedure and when the new symptoms first appeared was 2-7 days (mean, 4 days). To treat csf overdrainage, the vp shunts were ligated in 4 patients, and the shunts were revised in 2 patients. 5 out of the 6 patients with overdrainage had a good recovery, and 1 out of the 6 patients with overdrainage died. The clinical features of the patients without csf overdrainage include 25 fever/chills, 24 headache, 20 disturbed consciousness at emergency room, 7 visual disturbance, and 5 hearing impairment. The neuroimaging findings of patients without csf overdrainage included 7 cerebral infarction, 7 gyral enhancement, 3 basal cistern effacement, 3 pseudo-cyst, and 3 dilated virchow-robin space and 4 mass lesions. 15 out of the 45 patient with no overdrainage died.
 
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Brand NameUNKNOWN VALVE/SHUNT
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8579762
MDR Text Key144087943
Report Number2021898-2019-00169
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 05/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
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 Received04/11/2019
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: 05/03/2019 Patient Sequence Number: 1
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