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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 Bacterial Infection (1735); Meningitis (2389); Hydrocephalus (3272)
Event Date 01/17/2007
Event Type  Injury  
Manufacturer Narrative
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
Paola peretta, paola ragazzi, christian f. Carlino, pierpaolo gaglini & giuseppe cinalli. The role of ommaya reservoir and endoscopic third ventriculostomy in the management of post-hemorrhagic hydrocephalus of prematurity. Child's nervous system 23 (2007). Doi 10. 1007/s00381-006-0291-4. Abstract objective the aim of this study is to retrospectively evaluate a series of consecutive patients affected by posthemorrhagic hydrocephalus in prematurity, treated with an implant of an ommaya reservoir followed by ventriculoperitoneal (vp) shunt and/or endoscopic third ventriculostomy (etv) to evaluate the safety and efficacy of these treatment options in the management of the condition. Methods between 2002 and 2005, 18 consecutive premature patients affected by intra-ventricular haemorrhage (ivh) grades ii to iv, presenting with progressive ventricular dilatation, were operated for implant of an intraventricular catheter connected to a sub-cutaneous ommaya reservoir. Cerebrospinal fluid was intermittently aspirated percutaneously by the reservoir according with the clinical requirements and the echographic follow-up. The patients who presented a progression of the ventricular dilatation were finally operated for vp shunt implant or etv according with the mri findings. Results one patient had grade ii, 5 had grade iii, and 12 had grade iv i vh. The mean age at ivh diagnosis was 5. 2 days; the mean age at reservoir implant was 17. 3 days. The ommaya reservoir was punctured on an average basis of 11. 4 times per patient (range 2¿25), and the mean interval between aspirations was 2. 7 days. The mean csf volume per tap was 20 ml. One patient died for pulmonary complications during the study period. Out of the 17 survivors, 3 did not develop progressive ventricular dilatation, and their reservoir was removed; 14 developed progressive hydrocephalus, 5 of whom were implanted with a vp shunt and 9 received an etv. Amongst the five shunted patients, two were re-admitted for shunt malfunction and had their shunt removed after etv after 6. 1 and 20. 5 months, respectively. Amongst the nine patients who received an etv, five had to be re-operated for vp shunt implant at an average interval of 2. 17 months (range 9¿172 days) because of increasing ventricular dilatation. Two of them had a redo third ventriculostomy with shunt removal at 11 and 25. 1 months, respectively, after insertion. The first was reimplanted with a vp shunt 4 days later; the second remains shunt free. Therefore, at the end of the follow-up period, 10 out of 17 children affected by posthemorrhagic hydrocephalus in prematurity were shunt free (59%). Conclusions the combination of ommaya reservoir, vp shunt, and the aggressive use of etv as a primary treatment or as an alternative to shunt revision allowed for a significant reduction of shunt dependency in a traditionally shunt-dependent population. Further studies are warranted to optimise the algorithm of treatment in these patients. Reported events. 5. A 21 day old infant's first complication with the reservoir was obstruction leading to a reservoir replacement. 6. A 21 day old infant's first complication with the reservoir was meningitis (staphylococcus epidermidis) and required an external ventricular drainage. A vp shunt was eventually inserted. 7. Out of 17 infants, 3 patients (17. 6%) resolved hydrocephalus with ommaya tapping, whereas 14 developed a progressive ventricular dilatation, 5 of whom were implanted with a vp shunt at an average age of 2. 4 months and 9 received an etv at an average age of 2. 5 months.
 
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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 Key8145281
MDR Text Key129750663
Report Number2021898-2018-00555
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeIT
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 12/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2018
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 Received11/12/2018
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: 12/09/2018 Patient Sequence Number: 1
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