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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42856
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the nurse was attempting to adjust the valve with the handtools prior to opening the package, but the valve would not adjust past level 1. 0. Multiple attempts were made to no avail. A different valve was used andworked fine.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the valve was not adjusted on a metal table. Alignment was maintained between the adjustment tool and valve setting when the distance between the two was less than 15cm. When the pressure level was checked, the adjustment tool was at least 76cm away from the valve.
 
Manufacturer Narrative
The returned valve was not removed from the sealed sterile tyvek pouch. Laboratory personnel were able to adjust the performance level settings from 0. 5 to 2. 5 then down to 0. 5 again though the packaging. Therefore, the nature of the complaint could not be replicated. Due to the nature of the complaint the valve was not tested for patency, leak, reflux, siphon, valve flux, pressure-flow and preimplantation. 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, SMALL
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 Key8066944
MDR Text Key127066742
Report Number2021898-2018-00528
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCA
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,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42856
Device Catalogue Number42856
Device Lot NumberE41721
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
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

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