MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY ARES CATHETER, VENTRICULAR ANTIMICROBIAL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	91101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Irritation (1941)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient had surgery to remove a pineal cyst and developed hydrocephalus as a result.The patient was implanted with their device on (b)(6) 2018; however, the patient had a reaction to the device.The patient complained of irritation with the catheter and abdominal pain.The device was explanted on (b)(6) 2018 and was replaced with another device.The physician took a biopsy of the abdominal wall and sent it to pathology on the day of the extraction.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the patient's current status was okay.
Additional Manufacturer Narrative
Approximately 9 cm of the catheter was returned.The catheter was patent and met the requirements for leak testing.The edges of the catheter appeared jagged.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARES CATHETER, VENTRICULAR ANTIMICROBIAL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7535363
• Report Number: 2021898-2018-00263
• Device Sequence Number: 1551105
• Product Code: JXG
• UDI-Device Identifier: 00643169762640
• UDI-Public: 00643169762640
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2019
• Device Model Number: 91101
• Device Catalogue Number: 91101
• Device Lot Number: 0008727474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 05/30/2018; 06/20/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/05/2018; 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 101