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

Model Number	27816
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	08/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the shunt was not functioning and was replaced where the valve including the ventriculostomy dome and approximately 2cm of the peritoneal catheter was explanted.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the shunt seemed to underdrain as the patient¿s ventricles did not decrease in size.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for leak testing.However it did not meet the requirements for siphon, reflux and pressure flow testing.Proteinaceous debris was observed in the interior and on the 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 and siphon.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.¿ the device also appears distorted.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SNAP SHUNT ASSEMBLY, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6930220
• Report Number: 2021898-2017-00507
• Device Sequence Number: 13725573
• Product Code: JXG
• UDI-Device Identifier: 00643169010529
• UDI-Public: 00643169010529
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/30/2017

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: 01/31/2020
• Device Model Number: 27816
• Device Catalogue Number: 27816
• Device Lot Number: E26953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/15/2017; 11/22/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/14/2017; 11/30/2017
• 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: 53 YR