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

Catalog Number 42866

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Neurological Deficit/Dysfunction (1982); Visual Impairment (2138)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.All valves are 100% tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to medtronic neurosurgery that a patient with a history of acute obstructive hydrocephalus with a ventriculoperitoneal (vp) shunt that was placed 7 years ago presented approximately 3 months ago with reports of increased headaches, visual disturbances including diplopia, and ataxia; a shunt malfunction was diagnosed.It was confirmed that during an examination 3 years ago, the device showed normal function and worked well until a few months ago.The patient was taken to the operating room and the shunt was revised; a new distal system and valve were implanted.It was confirmed that the ventricular catheter worked well, but the patient presented again on several occasions with reports of "what [the patient] thought were low pressure headaches"; a shunt problem was reported.According to the report, there was a small curve of the distal catheter that was caudal to the anti-siphon device.The health care provider (hcp) thought this could be the cause of the previously noted problem, so a revision was performed.It was then reported that this was not the cause of the problem as the problem appeared to be in the valve system.The ventricular catheter was cut proximal to the shunt and a brisk ingress of spinal fluid, which was perfectly clear and under relatively high pressure, came out of the ventricular catheter without any event; a rubber shod was placed immediately.According to the report, it was concluded that there was a failure somewhere within the system of the valve and anti-siphon device.The patient's medical history included the following: copd, vp shunt placement approximately 7 years ago, headaches, and ataxia.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information received reported the cause of the shunt malfunction was not determined.The physician believed there was a valve failure possibly variable in "presentation.".

• 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
• 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: 6778991
• MDR Text Key: 82393904
• Report Number: 2021898-2017-00433
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 42866
• Device Lot Number: E10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 127