MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42866

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Nausea (1970); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)

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 had been having problems with their valve that was implanted last year, and had been needing several adjustments. It was stated they weren't draining enough. The patient was meeting with their surgeon next week. The patient's history included a posterior arachnoid cyst and hindbrain chiari malformation.

Manufacturer Narrative

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

Event Description

Additional information received reported the patient has had the shunt about 2 months and then started getting an increase in head pressure, sleepy, nauseated, and difficulty moving. They had reported to the neurosurgeon who had adjusted the shunt. This was the second time the shunt had been adjusted since the surgery. It did not relieve the symptoms. The patient has a follow-up appointment 3 months from now.

Manufacturer Narrative

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

• Brand Name: STRATA II VALVE, REGULAR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8486435
• MDR Text Key: 141025018
• Report Number: 2021898-2019-00138
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No