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

Model Number	92365
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Pain (1994); Complaint, Ill-Defined (2331); Irritability (2421); Cognitive Changes (2551)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient had their shunt placed on (b)(6) 2018.Prior to surgery, they were experiencing memory disturbances as well as urinary urgency.It was stated the patient had not seen improvement in their memory disturbances and felt like it had worsened; however their urinary disturbance had improved and no longer reported any urinary urgency.Their shunt had been adjusted from 1.5 to 2.0 prior to their (b)(6) 2018 visit.During the visit, the patient had experienced some personality changes that occurred twice which they didn't remember.Per the patient's spouse, their memory was much worse than before surgery.The patient was repeating the same questions every hour or so and having difficulty with short term memory.They were also experiencing involuntary movements particularly at night.The patient's shunt was adjusted from 2.0 to 1.5 in the emergency room about a week and a half ago (prior to their last visit on (b)(6) 2018).On (b)(6) 2018, the patient was feeling good, and per their spouse, they were doing a little better on some things.They stated they "saw little improvements in their speech and noticed that they were able to find more words, was still having some problems with their memory and agitation but was aware after that something happened." the patient's shunt was currently set at 1.5.The patient was last seen on (b)(6) 2018, where their spouse reported that they had not seen any improvement or worsening since the visit on (b)(6) 2018.They were still having memory problems as well as having their "anger fits," but other than that nothing had changed.Their shunt was turned down from 1.5 to 1.0 during the visit.On (b)(6) 2018, after having the shunt adjusted, their spouse noted the patient's symptoms had worsened.They also noted that they had some pain under their ribcage bilaterally.The device was explanted and replaced due to no dripping, not draining adequately, and the flow was slow.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that there were no factors known contributing to the failure.It was stated that the patient was doing well.
Additional Manufacturer Narrative
The returned valve was patent and meet the requirements for reflux and valve flux testing.However, it did not meet the requirements leak test, pressure-flow and preimplantation testing.The valve did not meet the requirements of the leak test due to a cut on the dome of the valve.It is unknown how or when the damaged occurred.The ifu that accompanies the product cautions that, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components¿.¿.There was proteinaceous debris noted in the interior and exterior of the device.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use that accompanies the device cautions 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¿.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 VALVE, REGULAR, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7993063
• Report Number: 2021898-2018-00506
• Device Sequence Number: 1682095
• Product Code: JXG
• UDI-Device Identifier: 00643169472952
• UDI-Public: 00643169472952
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2019

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 Model Number: 92365
• Device Catalogue Number: 92365
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 12/13/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 10/31/2018; 01/11/2019
• 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
• Patient Age: 78 YR
• Patient Weight: 78