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

Model Number	27818
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that after the valve was implanted, cerebrospinal fluid did not flow normally.The products were replaced without any issues and the patient¿s status was listed as alive ¿ no injury.
Additional Manufacturer Narrative
The returned valve could not be tested due to damage.The inlet was found to be disconnected from the rest of the valve.It is unknown how or when the damage occurred.The damage precludes all device testing.All valves are 100% tested at the time of manufacture.Approximately 86 cm of the peritoneal catheter was returned.It met the requirements for patency and leak testing.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis updated the returned valve could not be tested due to damage.The inlet was found to be disconnected from the rest of the valve.It is unknown how or when the damage occurred.The damage precludes all device 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 resulting in fluid reflux and 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.¿ all valves are 100% tested at the time of manufacture.Approximately 86 cm of the peritoneal catheter was returned.It met the requirements for patency and leak testing.Proteinaceous debris was observed on the exterior of the catheter.All catheters are 100% inspected 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 SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7584039
• Report Number: 2021898-2018-00281
• Device Sequence Number: 14082104
• Product Code: JXG
• UDI-Device Identifier: 00643169010505
• UDI-Public: 00643169010505
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/02/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 27818
• Device Catalogue Number: 27818
• Device Lot Number: E18787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 06/14/2018; 07/20/2018; 08/08/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/01/2018; 07/31/2018; 10/02/2018
• 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; Required Intervention