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

Catalog Number	44465
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	08/02/2017
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 lumbar peritoneal (lp) shunt system was implanted in (b)(6) 2016.According to the report, the physician stated that the valve pressure value was unable to be changed.Reportedly, since the physician considered the event was a product malfunction issue, a revision was performed to replace the product with another manufacturer's device.At the time of the report, the patient's status was alive-no injury.
Additional Manufacturer Narrative
The returned valve was patent.The valve was able adjust to all pressure level settings on the first attempt.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.The valve met the requirements for reflux and leak testing.However it did not meet the requirements for pressure-flow, and pre-implantation testing.There was proteinaceous debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use (ifu) that accompany the device indicate 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.¿ a review of the manufacturing records was not possible as no lot number was provided.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 NSC LP VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6828162
• Report Number: 2021898-2017-00462
• Device Sequence Number: 1118158
• Product Code: JXG
• UDI-Device Identifier: 00643169466210
• UDI-Public: 00643169466210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: 02/29/2020
• Device Catalogue Number: 44465
• Device Lot Number: D75842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 10/18/2017
• 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