CSF VENTRICULAR PORT, 16 MM, SIDE INLET 44010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-12 for CSF VENTRICULAR PORT, 16 MM, SIDE INLET 44010 manufactured by Medtronic Neurosurgery.

MAUDE Entry Details

• Report Number: 2021898-2019-00277
• MDR Report Key: 8786700
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-07-12
• Date of Report: 2019-09-27
• Date of Event: 2019-07-10
• Date Mfgr Received: 2019-09-24
• Device Manufacturer Date: 2018-12-07
• Date Added to Maude: 2019-07-12
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MGR. KATCHA TAYLOR
• Manufacturer Street: 9775 TOLEDO WAY
• Manufacturer City: IRVINE,CA MN 92618
• Manufacturer Country: US
• Manufacturer Postal: 92618
• Manufacturer Phone: 7635263305
• Manufacturer G1: MEDTRONIC NEUROSURGERY
• Manufacturer Street: 125 CREMONA DRIVE
• Manufacturer City: GOLETA CA 93117
• Manufacturer Country: US
• Manufacturer Postal Code: 93117
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CSF VENTRICULAR PORT, 16 MM, SIDE INLET
• Generic Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
• Product Code: LKG
• Date Received: 2019-07-12
• Returned To Mfg: 2019-09-11
• Model Number: 44010
• Catalog Number: 44010
• Lot Number: E57070
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC NEUROSURGERY
• Manufacturer Address: 125 CREMONA DRIVE GOLETA CA 93117 US 93117

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-12