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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Facial Nerve Paralysis (1846); Neurological Deficit/Dysfunction (1982); Paresis (1998); Complaint, Ill-Defined (2331)
Event Date 03/18/2005
Event Type  Injury  
Manufacturer Narrative
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
Antonis vakis, dimitris koutentakis, dimitris karabetsos, demosthenes ntouros. Intracerebral csf collection mimicking cerebral abscess in a patient suffering from cryptococcal meningitis. Journal of infection 51 (2005). Doi:10. 1016/j. Jinf. 2005. 02. 007. Abstract: we report a case of a large intracerebral csf collection formed along the course of the catheter of an ommaya-type reservoir (medtronic 12 mm), implanted in a patient suffered from cryptococcal meningitis in the frame of cll. This collection was at first diagnosed as intracerebral abscess but emergency craniotomy proves clear csf collection with no signs of infection. We describe the case and we discuss the issue of csf pressure pathophysiology and changes in flow dynamics, to patients with cryptococcal meningitis. Reported event: a (b)(6) male suffering from chronic lymphocytic leukemia (cll), was presented with absence seizures, headache, impaired consciousness (gcs score 13/15), meningismus, papilledema and right "hypacousis". A month before admission, the patient had undergone thoracotomy for a cryptococcal coccioma of the right middle pulmonary lobe. The immediate ct scan was normal. Lumbar puncture revealed elevated csf pressure (o25 cm h2o), low glucose and high protein concentration. India ink staining was positive for cryptococcus; serology of the csf revealed antigen for cryptococcus 1/100 on serial dilutions and csf¿s culture grew cryptococcus species. The following combination was initially administered to the patient: liposomal amphotericin b 300 mg/d, fluconazole 1000 mg/d, ceftriaxone 4 gr/d, teicoplanin 400 mg/d, metronidazole 1500 mg/d, and acyclovir 1500 mg/d. Repeating lumbar punctures were performed in order to control elevated icp. The patient¿s clinical condition was improved and thus we decided to implant an ommaya-type reservoir so as to perform regular csf drainage. Twenty days later, the patient¿s neurological state suddenly deteriorated with a decreased gcs (9/15), left hemiparesis and abducent nerve palsy. The mri scan showed a cavity filled with fluid along the course of the intracerebral catheter of the ommaya-type reservoir with a subcutaneous extension. The lesion demonstrated ringshaped gadolinium enhancement, marked oedema, and considerable mass effect. Combining the mri findings along with cll¿s history and subsequent immunosuppression, the diagnosis of a cerebral abscess was established. The lesion¿s low signal on diffusion mri sequence was the only sign against. The ommaya-type device was removed together with the bone flap, as it was thought out to be contaminated, during emergency craniotomy. Clear csf-like fluid with no signs of infection drained out of the area. Cultures were proved sterile. During the third p ost-operative day, elevated csf pressure required the placement of a lumbar drain. The patient¿s neurological condition gradually improved, but csf¿s pressure remained high. Two months later a v-p adjustable shunt from another manufacturer was placed.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
(b)(4).
 
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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 Key8097047
MDR Text Key128195343
Report Number2021898-2018-00536
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received11/07/2018
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 Initial

Patient Treatment Data
Date Received: 11/21/2018 Patient Sequence Number: 1
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