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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR NOVUS VALVE, LOW PRESSURE SHUNTS

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INTEGRA NEUROSCIENCES PR NOVUS VALVE, LOW PRESSURE SHUNTS Back to Search Results
Catalog Number XXX- NOVUS VALVE
Device Problem Product Quality Problem (1506)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Breast Neoplasm (2438)
Event Type  Injury  
Manufacturer Narrative
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. (b)(4). Linked to mfg report numbers: 2648988-2019-00005 and 2648988-2019-00006.
 
Event Description
Intracranial pressure and brain monitoring xiv published (2012) "idiopahic normal pressure hyrdocephalus : results of prospective cohort of 236 shunted patients. " aim : to describe the outcomes and complication rates in 236 patients with idiopathic normal pressure hydrocephalus(inph) after treatment. Patients and methods: between march 1998 and june 2007, 257 consecutive patients with suspected inph syndrome were evaluated in the department of neurosurgery at a university hospital. Among a cohort of 257 patients with suspected inph, 244 were shunted and 236 were followed up at 6 months after shunting (145 men [61. 4%] and 91 women [38. 6%] with a median age of 75 years). The study protocol of these patients included clinical, radiological, neuropsychological and functional assessment. The decision to shunt patients was based on continuous intracranial pressure monitoring and csf dynamics studies. A differential low-pressure valve system, always combined with a gravity compensating device, was implanted in 99% of the patients. Differential low-pressure valve system was implanted and combined with a gravity compensating device in 233 of the 236 patients. In the remaining three patients, a medium pressure valve with an antisiphon device was implanted. The types of valve used in the present series were programmable hakim medos valve (medos s. A. ) + low-pressure gravity compensating accessory (gca) (nmt neurosciences implants), delta valve (performance level of 0. 5) with antisiphon device (medtronic ps medical), ventriculo-peritoneal catheter with a low-pressure gca (nmt neurosciences implants), dual swith mietke (braun-aesculap), hakim medos valves (nmt neurosciences implants), low-pressure novus valve with an antisiphon (integra), and medium-pressure novus valve with an antisiphon (integra). Results: early postsurgical complications were found in 13 of the 243 shunted patients (four (4) subdural hematoma, two (2) shunt malfunctions, four (4) systemic complications, one (1) postural hypoacusia, one (1) parenchymal hematoma, one (1) hemorrhagic complication when the burr hole was performed). Six months after shunting, the follow- up ct showed asymptomatic subdural collections (hygromas) in 8 of the 236 patients who remained under follow-up. None of these patients required treatment. Of the 236 patients, post-surgical complications were found in 7, consisting of 6 subdural hematomas (3 acute and 3 chronic) and a distal catheter infection. No shunt malfunctions were observed in this period. Conclusion: a high percentage of patients with inph can improve after shunting, with early and late complication rates of less than 12%.
 
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Brand NameNOVUS VALVE, LOW PRESSURE
Type of DeviceSHUNTS
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
road 402 north, km 1.2
anasco PR 00610
Manufacturer (Section G)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
anasco PR 00610
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8232182
MDR Text Key132567624
Report Number2648988-2019-00004
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K961859
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 12/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX- NOVUS VALVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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