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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 Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Hemorrhage, Intraventricular (1892); Unspecified Infection (1930); Complaint, Ill-Defined (2331); Hydrocephalus (3272)
Event Date 07/01/2012
Event Type  Injury  
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
Lin jian, sheng hang-song, lin zheng-lang, yu li-sheng, wang heng, zhang nu. Implantation of ommaya reservoir in extremely low weight premature infants with posthemorrhagic hydrocephalus: a cautious option. Childs nervous system 28 (2012). Doi 10. 1007/s00381-012-1847-0 abstract: objective this study aims to evaluate effects and complications of the implantation of ommaya reservoir in premature infants with posthemorrhagic hydrocephalus (phh). Methods: the effects and complications of the implantation of ommaya reservoir in seven premature infants with phh were retrospectively analyzed. Intracapsular puncture of the reservoir was performed for draining cerebrospinal fluid. Results: seven extremely low-weight premature infants with phh (birthweight less than 1,000 g) were treated with the placement of an ommaya reservoir. Ommaya reservoirs in five infants were removed, but were retained in two infants. Two premature infants had to undergo ventriculoperitoneal (vp) shunt. Postsurgical major complications (including skin dehiscence, cerebrospinal fluid (csf) infection, ventricular hemorrhage, and csf leak) occurred in 57 % of all patients. Three infants of skin dehiscence and csf leak occurred. Two infants of csf infection occurred, as well as one clinically significant secondary hemorrhage. Six infants survived, and one died. Conclusion: the implantation of ommaya reservoir is a cautious option of treating low-weight premature infants with phh because of a relatively high complication rate. However, vp shunt surgery may be avoided in some infants. Reported events: a (b)(6) premature infant experienced a cerebrospinal fluid (csf) leak and skin dehiscence that occurred after implantation of the ommaya reservoir. The infant developed a csf infection, and the reservoir had to be removed. The parents of the infant refused to perform an external csf drainage. Treatment of the infant included drugs that control csf infection and decrease csf production. The infant survived with giant ventricle, eventually. A (b)(6) premature infant experienced a cerebrospinal fluid (csf) leak and skin dehiscence that occurred after implantation of the ommaya reservoir. The infant developed a csf infection after skin dehiscence in the wound site. The scalp was closed using 4. 0 prolene sutures again, and the effusion was drained. A (b)(6) premature infant suffered from a secondary ventricular hemorrhage 2 days after surgery. The implanted reservoir was clogged and had to be washed with saline for proper functioning. Unfortunately, the infant ultimately died of complications unrelated to the reservoir. A (b)(6) premature infant experienced a cerebrospinal fluid (csf) leak and skin dehiscence that occurred after implantation of the ommaya reservoir. This infant also experienced a decrease in ventricular size after draining csf, but ct image showed a dilated ventricle after stopping draining csf. It was noted this infant had developed progressive hydrocephalus. After 10 days of vp shunt and removing ommaya reservoir, ct image showed a decreasing ventricle and shrunken bone suture. A (b)(6) premature infant developed progressive hydrocephalus. The reservoir was removed, and a vp shunt was implanted.
 
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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 Key8105855
MDR Text Key128409084
Report Number2021898-2018-00538
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
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 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
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 Received11/08/2018
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: 11/27/2018 Patient Sequence Number: 1
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