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

Model Number	27816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Staphylococcus Aureus (2058); Sepsis (2067)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported the physician admitted the patient due to an infection and ventriculitis.The physician did blood tests and confirmed that it was a staph infection.The manufacturer representative was in theatre and opened the products in theatre.It was stated the products were handled correctly.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for siphon, pressure-flow, and pre-implantation testing.However, the device did not meet the expectations for reflux testing.There was proteinaceous debris noted in the interior and exterior of the device.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve and may result 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.¿ the returned valve also did not meet the requirements for leak due to a tear in the top of the reservoir.It is unknown how or when this damage occurred.The ifu caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ the ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.All valves are 100% tested at the time of manufacture.Approximately 120 cm of the peritoneal catheter was returned.The catheter patent and met the requirements for leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.All catheters are 100% inspected at the time of manufacture.Approximately 8 cm of the snap catheter was returned.The catheter patent and met the requirements for leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the cause of the infection was unknown.It was also stated the infection was sepsis.The current status of the patient was reportedly unknown.

• Brand Name: STRATA II SNAP SHUNT, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7108426
• Report Number: 2021898-2017-00647
• Device Sequence Number: 1091893
• Product Code: JXG
• UDI-Device Identifier: 00643169010529
• UDI-Public: 00643169010529
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 27816
• Device Catalogue Number: 27816
• Device Lot Number: E05156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/20/2018
• 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
• Patient Age: 34 YR
• Patient Weight: 87