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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, CONTOURED SMALL, LOW SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, CONTOURED SMALL, LOW SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Erosion (1750)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on (b)(6) 2017, the patient's parents contacted the doctor because they noticed would break down at the shunt site with exposure of the shunt tubing. It was noted as protruding from their scalp. The doctor advised removal of the shunt due to the high risk of infection from an exposed shunt. On (b)(6) 2017, the patient's shunt was removed and replaced with an external ventricular drain (evd). On (b)(6) 2017, after 3 days of negative cultures to confirm no infection, the evd was removed, and a shunt was implanted.
 
Manufacturer Narrative
Previous reported information no longer applies. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the patient's may admission for chemotherapy, their shunt tubing was visible, and there was wound dehiscence. On (b)(6) 2017, the patient's doctors attempted to suture it by closing the wound with nylon suture, bacitracin, and antibiotics were given. Due to wound healing problems and infection as a result of the immunocompromised state of an infant on chemotherapy, that proved unsuccessful. On (b)(6) 2017, the patient was admitted to revise their shunt due to further shunt complications. The shunt was tapped at the patient's bedside. On (b)(6), the doctor removed their shunt, debrided their scalp tissue, and placed an external ventricular drain (evd). On (b)(6) 2017, the doctor placed a new shunt at another location on the other side of the patient's head.
 
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Brand NameCSF-FLOW CONTROL VALVE, CONTOURED SMALL, LOW
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 Key8634039
MDR Text Key145861191
Report Number2021898-2019-00190
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K841442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Model Number42312
Device Catalogue Number42312
Device Lot NumberD81411
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 Manufactured06/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/22/2019 Patient Sequence Number: 1
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