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

Catalog Number 42856

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Headache (1880); Visual Impairment (2138); Vomiting (2144)

Event Date 10/09/2016

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 the patient showed clear symptoms of underdrainage and device failure.According to the report, the patient experienced drowsiness, headaches, vomiting, and diplopia.A ct showed enlarged ventricles.Reportedly, the device was replaced with a new device, which worked better.It was stated the patient¿s diplopia and headaches had disappeared, but they still had amnesia.

Manufacturer Narrative

The returned valve was patent.The valve met the requirements for siphon, reflux, pre-implantation, and leak testing.However, the valve did not meet the requirements for pressure-flow testing.There was proteinaceous debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use (ifu) that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ 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.

Manufacturer Narrative

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

• Brand Name: STRATA II VALVE, SMALL
• 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: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6113797
• MDR Text Key: 60366690
• Report Number: 2021898-2016-00423
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided; 11/18/2016
• Supplement Dates FDA Received: 12/15/2016; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 28 YR