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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA NSC LP VALVE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 44465
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that prior to the procedure, the physician was unable to adjust the valve. This was attempted 5-6 times and the valve was never implanted. A different valve was used to complete the procedure without issue. It was noted that the manufacturer representative was able to adjust the valve, however the valve was still replaced as the physician had experienced issues.
 
Manufacturer Narrative
The returned valve was returned unopened in the original sterile packaging. Laboratory personnel were able to adjust the valve was adjusted to all performance level settings through the packaging. Therefore, the nature of the complaint could not be replicated by laboratory personnel. The valve was not tested for valve flux, reflux, siphon, leak, pressure-flow, or preimplantation testing as it was not related to the complaint. 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 NSC LP VALVE
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 Key8201158
MDR Text Key131709991
Report Number2021898-2018-00593
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K091312
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 02/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number44465
Device Catalogue Number44465
Device Lot NumberE42753
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2018
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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