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

Catalog Number	44420
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned valve was patent and met the requirements for leak testing.The valve was returned at pl 0.5 and was not adjustable.This precluded pressure-flow and pre-implantation testing.There was proteinaceous debris noted in the interior and exterior of the device.Debris within the valve may interfere with the adjustment mechanism resulting in fluid reflux and in difficulty adjusting 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¿.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.Approximately 17 cm of the lumbar catheter was returned.The returned catheter was patent and met the requirements for leak testing.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of the manufacture.Approximately 60 cm of the peritoneal catheter was returned.The catheter was returned in two separate pieces, one measuring 6 cm, and the other piece measuring 54 cm.The returned catheter was patent.However it did not meet the requirements for leak testing due to a tear observed approximately 6 cm from the proximal end.It is unknown how or when this damage occurred.The catheter met all of the requirements for the tensile strength and ultimate elongation tests.The instructions for use that accompany the device cautions that low tear strength is a characteristic of most unreinforced silicone elastomer materials, and that care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks, or tears.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of the manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the valve was obstructed and could not drain cerebrospinal fluid (csf) after implant.The valve was replaced with another valve to successfully drain csf and there was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC LP SHUNT KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6153613
• Report Number: 2021898-2016-00464
• Device Sequence Number: 19023330
• Product Code: JXG
• UDI-Device Identifier: 00643169010796
• UDI-Public: 00643169010796
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2016

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: 05/31/2020
• Device Catalogue Number: 44420
• Device Lot Number: D83888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: 11/08/2016
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 09/27/2017
• 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