MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 27819

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dizziness (2194); Complaint, Ill-Defined (2331); Irritability (2421)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was implanted with a pressure adjustable shunt on (b)(6) 2016 due to hydrocephalus.In (b)(6) 2017, the patient began to feel dizzy and the brain had a sound of water.After the patient went to the hospital in february to have the pressure adjusted, the doctor suggested to be observed for a period of time.In (b)(6) 2018, the patient was feeling irritable, had dizziness, and frequent water sound in the brain.The patient immediately went to the hospital for a brain ct examination, and the doctor judged that it might be caused by over shunting.It was recommended to have the pressure adjusted.

Manufacturer Narrative

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

Event Description

Additional information reported that the patient had not contacted the physician for the adjustment, and since there was no contact, no additional information was able to be provided about the patient.It was also stated that the doctor didn't have any doctor's order so there was no pressure adjustment.

• Brand Name: STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE
• 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: 7555235
• MDR Text Key: 109624125
• Report Number: 2021898-2018-00276
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27819
• Device Catalogue Number: 27819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2018
• 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
• Patient Age: 57 YR