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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR, WITH BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 92866
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure, the delta chamber of the valve was found to be leaking. It was stated there were no external/environmental factors identified that may have led to the leaking. There was no patient impact.
 
Manufacturer Narrative
The returned valve was patent. The valve met the requirements for the valve flux test. It did not meet the requirements for leak, reflux, siphon, pressure-flow, and preimplantation testing due to damage to the delta chamber casing. The instructions for use 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¿¿ there was proteinaceous debris on the interior and exterior of the valve. The instructions for use cautions, ¿the system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris. ¿ 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 VALVE, REGULAR, 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 Key8138251
MDR Text Key129591301
Report Number2021898-2018-00551
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model Number92866
Device Catalogue Number92866
Device Lot NumberE48258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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