MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	42965
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	02/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product testing is in progress.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.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 to medtronic neurosurgery that the valve was not allowing cerebrospinal fluid (csf) to drain.According to the report, the surgeon decided to revise the shunt system and test all components.It was stated that csf flowed from the ventricular catheter.The surgeon then connected primed manometer tubing to the proximal end of the valve and raised the tubing to a sufficient height.No flow of fluid through the tubing was noted.It was then indicated that the surgeon disconnected the valve from the peritoneal catheter and connected the manometer tubing to the catheter.Fluid flowed through the tubing.The surgeon concluded that valve was blocked and replaced the valve.
Additional Manufacturer Narrative
Additional information received reported the device was adjusted once after implant.According to the report, this was the patient¿s first shunt and they did not undergo any mris while it was implanted.It was noted that the device was not bathed in chemicals or antibiotics prior to implant.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The valve was dissected to investigate the cause for the occlusion described by the surgeon.The ruby ball was still lodged into the cone upon disassembly, and the large amounts of biological debris is believed to be the reason why the ball remained lodged into the cone, which resulted in the occluded behavior noted by the surgeon that resulted in an inability for csf to flow through the valve mechanism.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATAMR VALVE, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6414924
• Report Number: 2021898-2017-00115
• Device Sequence Number: 528573
• Product Code: JXG
• UDI-Device Identifier: 00643169692701
• UDI-Public: 00643169692701
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/10/2017

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: 04/30/2019
• Device Catalogue Number: 42965
• Device Lot Number: E12266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided; 03/15/2017; 11/08/2017
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/13/2017; 09/06/2017; 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1702-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR