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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 27818
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Unspecified Infection (1930); Vomiting (2144); Dizziness (2194)
Event Date 10/23/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient was implanted in (b)(6) 2018 due to hydrocephalus secondary to brain atrophy. The patient improved following implant, but came back within a week due to vomiting and dizziness. A ct scan was suggestive of hydrocephalus and a revision was done to remove the shunt. The shunt was blocked near the delta chamber and likely infected as there was granulation and crust seen at the chamber. The shunt was to be replaced.
 
Manufacturer Narrative
The returned valve was patent. Prior to the patency test the valve¿s pl level was difficult to adjust; however, after the patency test the valves pl adjustment performed as expected. After the patency test, the valve met the requirements for valve flux, leak, reflux, siphon, preimplantation, and pressure-flow testing. Particulates/debris were observed in the delta chamber. It is unknown how or when these particulates/debris entered the valve. The ifu cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling. Introduction of contaminants could result in improper performance of the shunt system. Particulate matter that enters the shunt system may result in shunt occlusion¿¿ damage was observed on the inlet and on the flange. It is unknown how or when this damage occurred. The ifu cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components. Such damage may lead to loss of shunt integrity¿¿ all valves are 100% tested at the time of manufacture. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE
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 Key8064638
MDR Text Key126942290
Report Number2021898-2018-00526
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K042465
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 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number27818
Device Catalogue Number27818
Device Lot NumberE47028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
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: 11/13/2018 Patient Sequence Number: 1
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