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

Model Number 95001

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Incontinence (1928); Pain (1994); Blurred Vision (2137); Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient was getting worse for their shunt procedure in 2017.Their symptoms had been: vomiting, blurred vision, lack of energy, pain in areas from ear to their stomach, and they had been wearing diapers from bladder issues.Their last shunt adjustment was (b)(6) 2019 after an mri.

• Brand Name: ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT
• Type of Device: SHUNT, 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 Key: 8729128
• MDR Text Key: 149080435
• Report Number: 2021898-2019-00248
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169762664
• UDI-Public: 00643169762664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2018
• Device Model Number: 95001
• Device Catalogue Number: 95001
• Device Lot Number: 0008517412
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1