STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE 27819

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-30 for STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE 27819 manufactured by Medtronic Neurosurgery.

MAUDE Entry Details

• Report Number: 2021898-2020-00110
• MDR Report Key: 9898156
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-03-30
• Date of Report: 2020-03-30
• Date Mfgr Received: 2020-03-11
• Device Manufacturer Date: 2019-08-12
• Date Added to Maude: 2020-03-30
• 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: KATCHA TAYLOR
• Manufacturer Street: 9775 TOLEDO WAY
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal: 92618
• Manufacturer Phone: 9496801345
• 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: STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE
• Generic Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Product Code: JXG
• Date Received: 2020-03-30
• Model Number: 27819
• Catalog Number: 27819
• Lot Number: E70404
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• 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	1. Hospitalization; 2. Required No Informationntervention	2020-03-30