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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PS MEDICAL, INC. STRATA; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC PS MEDICAL, INC. STRATA; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42866
Device Problems Poor Quality Image (1408); Product Quality Problem (1506); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 03/10/2021
Event Type  malfunction  
Event Description
A medtronic ventriculo-peritoneal (vp) shunt was implanted into a patient.Post-operatively it was radiographically recognized that the shunt had poor radio-opaque markings required to confirm its orientation after implantation and pressure settings.The lot number for this device is 0220812938 and the log number is 1507121721.In addition to this implanted device, another medtronic strata ii valve shunt which was not implanted was found to have poor radiographic markings as well.The lot number for this defective device is 0219000135; the model number is 42866; the tag id number is (b)(4).
 
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Brand Name
STRATA
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC PS MEDICAL, INC.
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key11553023
MDR Text Key241787171
Report Number11553023
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number42866
Device Lot Number0220812938
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/16/2021
Event Location Hospital
Date Report to Manufacturer03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age28105 DA
Patient Weight79
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