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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42955
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Edema (1820); Erythema (1840); Swelling (2091); Vomiting (2144); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient had retained counsel who alleged a revision of the shunt was required.
 
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Brand NameSTRATAMR 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 Key7865806
MDR Text Key119865970
Report Number2021898-2018-00452
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2019
Device Model Number42955
Device Catalogue Number42955
Device Lot NumberE13484
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberZ-1702-2017

Patient Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1
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