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

Model Number	42856
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	11/27/2018
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 the valve malfunctioned during the procedure.It was stated that valve had an issue priming.The procedure was completed using another valve which worked properly.There was no patient impact.
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 valve did not have patient contact.It was stated the valve did not function properly and there were no "out of the ordinary situational issues" that could be identified that would contribute to the reported issue.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for valve flux, siphon, reflux, pressure-flow, pre-implantation, and leak testing.The laboratory personnel were able to adjust the valve normally.Therefore, the nature of the complaint could not be replicated by laboratory personnel.Particulates were observed on the interior and exterior of the valve.It is not known how or when these particulates entered the valve.The instructions for use cautions that, ¿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.¿ base misalignment was observed in the reservoir.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity¿¿ 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 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: 8171483
• Report Number: 2021898-2018-00568
• Device Sequence Number: 11114235
• Product Code: JXG
• UDI-Device Identifier: 00643169975828
• UDI-Public: 00643169975828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2019

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: 07/31/2020
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: E36957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 01/18/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/07/2019; 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 MO