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

Catalog Number	42856
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for siphon, and leak testing.However, the valve did not meet the requ irements for reflux, pressure-flow, and pre-implantation testing.There was proteinaceous debris noted 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 and resulting in fluid reflux.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 showed no anomalies.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient had a 3 tesla mr scan on (b)(6) 2017.According to the report, following the scan, the patient worsened and ¿they suspected from the adjusted level¿ of the valve.The performance level was adjusted, but nothing had been changed in the patient's status.As a result of this, the clinic believed that the adjustment mechanism of the valve was not working properly and was broken.Therefore, the device was replaced with a new one.Reportedly, the patient's status was okay and fine after the revision and would be leaving the hospital on (b)(6) 2017.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for siphon, and leak testing.However, the valve did not meet the requ irements for reflux, pressure-flow, and pre-implantation testing.There was proteinaceous debris noted 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 and resulting in fluid reflux.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 showed no anomalies.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6571296
• Report Number: 2021898-2017-00272
• Device Sequence Number: 13475320
• Product Code: JXG
• UDI-Device Identifier: 00613994804631
• UDI-Public: 00613994804631
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 42856
• Device Lot Number: D59668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 07/14/2017; 07/14/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 08/09/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 2 YR
• Patient Weight: 10