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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 95001
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 during the patient's may admission for chemotherapy, their shunt tubing was visible, and there was wound dehisc ence. 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 NameARES ANTIBIOTIC-IMPREGNATED CATHETER KIT
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 Key8634350
MDR Text Key145898747
Report Number9612164-2019-01901
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
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 Date08/16/2018
Device Model Number95001
Device Catalogue Number95001
Device Lot Number0008494059
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 Manufactured02/14/2017
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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