STRATA 42314 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-25 for STRATA 42314 * manufactured by Medtronic Neurosurgery.

Event Text Entries

[2645907] Patient has history of removal of astrocytoma approx 15 years ago which required a vp (ventriculoperitoneal) shunt. She has had multiple revisions with the last being 3 years ago. After a 4 day history of headaches, she returned to the er where she was found to have a sluggish refuel of her reservoir and the ct scan of the head showed enlargement in the ventricular size. The patient returned to or for proximal shunt revision. Surgeon found slow flow csf from old intraventricular catheter.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2608796
• MDR Report Key: 2608796
• Date Received: 2012-05-25
• Date of Report: 2012-05-25
• Date of Event: 2012-05-11
• Report Date: 2012-05-25
• Date Reported to FDA: 2012-05-25
• Date Added to Maude: 2012-06-11
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: STRATA
• Generic Name: VP SHUNT, CONTROL VALVE
• Product Code: JXG
• Date Received: 2012-05-25
• Model Number: 42314
• Catalog Number: *
• Lot Number: C34769
• ID Number: *
• Device Availability: Y
• Device Age: 3 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC NEUROSURGERY
• Manufacturer Address: 125 CREMONA DRIVE GOLETA CA 93117 US 93117

Device Sequence Number: 2

• Brand Name: STRATA
• Generic Name: VENTRICULAR CATHETER
• Product Code: HCA
• Date Received: 2012-05-25
• Model Number: 41101
• Catalog Number: *
• Lot Number: A71356
• ID Number: *
• Device Availability: Y
• Device Age: 3 YR
• Device Sequence No: 2
• 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	2012-05-25