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

Model Number	27820
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	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the shunt did not drain cerebrospinal fluid.The shunt was repositioned multiple times as well as the valve was pumped to encourage drainage without any success.It was stated the device was replaced with another manufacturer's device.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for valve flux, reflux, siphon, preimplantation and pressure-flow testing.Water was able to flow though the valve during testing.Therefore, the nature of the complaint could not be replicated by laboratory personnel.It did not meet the requirements for leak testing due to a puncture in the reservoir.It is unknown how or when the damage occured.The ifu cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of component.Such damage may lead to loss of shunt integrity¿¿ proteinaceous debris was observed on the exterior of the valve.Crystalline debris was observed on the interior of the valve.The in structions for use cautions, ¿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¿ and ¿care must be taken to ensure that particulate contaminates are not introduced into the shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion, or may also hold pressure/flow controlling mechanisms open, resulting in overdrainage.¿ 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 UNITIZED 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: 8561761
• Report Number: 2021898-2019-00165
• Device Sequence Number: 1852292
• Product Code: JXG
• UDI-Device Identifier: 00643169975644
• UDI-Public: 00643169975644
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 27820
• Device Catalogue Number: 27820
• Device Lot Number: E33244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR