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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATA NSC VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 42365
Device Problems Inaccurate Flow Rate (1249); Appropriate Term/Code Not Available (3191)
Patient Problems Unspecified Infection (1930); Therapeutic Response, Decreased (2271); Coma (2417)
Event Date 10/24/2016
Event Type  Injury  
Manufacturer Narrative
The returned valve was patent. It met the requirements for pressure-flow, and pre-implantation. However, it did not meet requirements for reflux testing. Proteinaceous debris was noted within the interior and exterior of the valve. Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux. The instructions for use (ifu) that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system. The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris. ¿ the valve also did not meet the requirements for leak testing due to multiple tears observed in the top of the reservoir. It is unknown how or when this damage occurred. The ifu cautions that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance. ¿ the ifu also cautions that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, crushing or breaking of components. ¿ a review of the manufacturing records was not possible as no lot number was provided. All valves are 100% tested at the time of manufacture.
 
Event Description
It was reported to medtronic neurosurgery that the device was implanted in (b)(6) 2015 due to hydrocephalus. According to the report, from 2015 to 2016, the pressure level of the device changed by itself several times causing poor flow, increased intracranial pressure, an intracranial infection, and a coma. Reportedly, the patient underwent hospitalization and the device was explanted and replaced. The report stated that the patient¿s current status is stable.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA NSC VALVE, REGULAR
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
bob shokoohi
125 cremona drive
goleta, CA 93117
8055718725
MDR Report Key6125915
MDR Text Key60843282
Report Number2021898-2016-00431
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K033850
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 10/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number42365
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2016
Was Device Evaluated by Manufacturer? Yes
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: 11/23/2016 Patient Sequence Number: 1
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