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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC STRATA VALVE PROGRAMMABLE SHUNT ; MEDTRONIC VALVE STRATA VALVE
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MEDTRONIC STRATA VALVE PROGRAMMABLE SHUNT ; MEDTRONIC VALVE STRATA VALVE Back to Search Results
Model Number REF42866
Device Problems Difficult to Interrogate (1331); Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
Patient Problem Hematoma (1884)
Event Date 12/27/2016
Event Type  Injury  
Event Description
On (b)(6) 2016 patient underwent a placement of right frontal ventriculoperitoneal shunt using bactiseal catheters and a strata 2 valve set to 1.5.The patient was discharged.Post discharge, the patient had bilateral subdural hematomas; there was a concern for valve malfunctioning.On (b)(6) 2016 patient underwent exploration and interrogation of right frontal proximal shunt catheter and valve and removal of right frontal catheter and valve.The mfr was notified; the product was removed from the shelf.On 02/02/2017 notification received product was a class 2 device recall.
 
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Brand Name
STRATA VALVE PROGRAMMABLE SHUNT
Type of Device
MEDTRONIC VALVE STRATA VALVE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6393198
MDR Text Key69640226
Report Number6393198
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/13/2019
Device Model NumberREF42866
Device Catalogue Number42866
Device Lot NumberE12591
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/28/2017
Distributor Facility Aware Date12/27/2016
Device Age NA
Event Location Hospital
Date Report to Manufacturer02/28/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age86 YR
Patient Weight77
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