• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

MEDTRONIC NEUROSURGERY STRATA VALVE, REGULAR JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 42866
Device Problem Improper flow or infusion
Event Date 10/17/2012
Event Type  Injury  
Event Description

It was reported to medtronic neurosurgery that the valve was explanted during a shunt revision. According to the report, during postoperative testing the valve showed no resistance at pressure level setting 0. 5.

 
Manufacturer Narrative

The product was unavailable for return. Therefore, an evaluation of the device performance was not possible. A review of the manufacturing records was not possible as no lot number was provided. All of our valves are 100% tested at the time of manufacture.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRATA VALVE, REGULAR
Type of DeviceJXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section F)
MEDTRONIC NEUROSURGERY
125 cremona dr.
goleta CA 93117
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona dr.
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona dr.
goleta CA 93117
Manufacturer Contact
jeffrey henderson
125 cremona dr.
goleta , CA 93117
(805) 571 -8445
Device Event Key2878788
MDR Report Key2850613
Event Key2747148
Report Number2021898-2012-00389
Device Sequence Number1
Product CodeJXG
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 10/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number42866
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received10/18/2012
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/16/2012 Patient Sequence Number: 1
-
-