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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN NON-DELTA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-B
Device Problems Disconnection (1171); Obstruction of Flow (2423); Device Dislodged or Dislocated (2923); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Death (1802); Headache (1880); Neurological Deficit/Dysfunction (1982); Seizures (2063); Dysphasia (2195); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Cognitive Changes (2551); No Code Available (3191)
Event Date 06/04/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Bujung hong, manolis polemikos, hans e. Heissler, christian hartmann, makoto nakamura, and joachim k. Krauss. Challenges in cerebrospinal fluid shunting in patients with glioblastoma. Fluids and barriers of the cns 15 (2018). Doi : 10. 1186/s12987-018-0101-x abstract background: cerebrospinal fluid (csf) circulation disturbances may occur during the course of disease in patients with glioblastoma. Ventriculoperitoneal shunting has generally been recommended to improve symptoms in glioblastoma patients. Shunt implantation for patients with glioblastoma, however, presents as a complex situation and produces different problems to shunting in other contexts. Information on complications of shunting glioma patients has rarely been the subject of investigation. In this retrospective study, we analysed retrospectively the course and outcome of glioblastoma-related csf circulation disturbances after shunt management in a consecutive series of patients within a period of over a decade. Methods: thirty of 723 patients with histopathologically-confirmed glioblastoma diagnosed from 2002 to 2016 at the department of neurosurgery, hannover medical school, underwent shunting for csf circulation disorders. Treatment history of glioblastoma and all procedures associated with shunt implementation were analyzed. Data on follow-up, time to progression and survival rates were obtained by review of hospital charts and supplemented by phone interviews with the patients, their relations or the primary physicians. Results: mean age at the time of diagnosis of glioblastoma was 43 years. Five types of csf circulation disturbances were identified: obstructive hydrocephalus (n
=
9), communicating hydrocephalus (n
=
15), external hydrocephalus (n
=
3), trapped lateral ventricle (n
=
1), and expanding fluid collection in the resection cavity (n
=
2). All patients showed clinical deterioration. Procedures for csf diversion were ventriculoperitoneal shunt (n
=
21), subduroperitoneal shunt (n
=
3), and cystoperitoneal shunt (n
=
2). In patients with lower karnofsky performance score (kps) (< 60), there was a significant improvement of median kps after shunt implantation (p
=
0. 019). Shunt revision was necessary in 9 patients (single revision, n
=
6; multiple revisions, n
=
3) due to catheter obstruction, catheter dislocation, valve defect, and infection. Twenty-eight patients died due to disease progression during a median follow-up time of 88 months. The median overall survival time after diagnosis of glioblastoma was 10. 18 months. Conclusions: csf shunting in glioblastoma patients encounters more challenge and is associated with increased risk of complications, but these can be usually managed by revision surgeries. Csf shunting improves neurological function temporarily, enhances quality of life in most patients although it is not known if survival rate is improved. Reported events. Shunt failure occurred in nine patients. The main symptoms of shunt failure were impairment of consciousness (n
=
10), cephalgia (n
=
8), and focal neurological deficits (n
=
5). Other symptoms included seizures, gait disorder, and aphasia (n
=
5). In three patients, routine follow-up imaging showed persistent hydrocephalus, and valve malfunction. Neither specific symptoms nor new neurological deficits were evident in these patients. A total of 16 revision surgeries were performed in 9 (30. 0%) adult patients (7 men, 2 women; mean age 55 years) due to various complications including wound dehiscence with pneumocephalus, delayed fluid collection in resection cavity, valve and proximal catheter obstruction, proximal catheter obstruction, proximal catheter dislocation, distal catheter dislocation, valve malfunction, delayed trapped ventricle and csf collection in cavity, and intracerebral abscess. Of the 9 patients who had shunt failures in this literature article, 2 of the patients were identified to have the manufacturer's device, but it is unclear whether the shunt malfunctions and revisions were involved with the 2 patients that had the manufacturer's device.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameUNKNOWN NON-DELTA 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 Key7678922
MDR Text Key113747275
Report Number2021898-2018-00336
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-B
Device Catalogue NumberUNKNOWN-B
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 Received08/08/2018
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

Patient Treatment Data
Date Received: 07/11/2018 Patient Sequence Number: 1
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