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

Model Number	42365
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 customer was having a shunt malfunction on one of their patients.According to the report, the device was stuck at a high setting, and if they couldn't get it working, they would have to take the patient to the operating room (or) to revise the system.It was stated they had repeatedly tried to adjust the setting of the valve, but it didn't seem to move.The manufacturer representative (rep) asked about their adjustment technique and verified that they had used both thestrata adjustment tools and the stratavarius system to attempt reprogramming.The rep offered a few pointers on the adjustment techniques and also told them they would come into the hospital to observe their process.Reportedly, once the rep was at the hospital and observed their programming technique, the valve was flickering between 2.0 and 2.5.They held the magnet closer and adjusted it back and forth.Afterwards, they attempted to reset the valve to 1.0 using the stratavarius programmer.At this attempt, the valve seemed to be set at 1.0.The rep verified the reading at 1.0.Radiology was then called in to perform a bedside confirmation x-ray of the valve.The x-ray was read and compared to their x-ray guide.The valve reading seemed to be set between 1.5 and 2.0.At that point, the resident adjusted the valve to 2.5 and confirmed the reading and then repeated the x-ray.The reading proved the valve to be set at 1.0 even though the setting read 2.5 with the stratavarius.Additional information received reported that apparently, after the patient was admitted into the hospital, another service ordered a magnetic resonance imaging (mri).Neurosurgery was not consulted about the mri.They attempted to adjust the valve on friday, and the rep was contacted early saturday morning.It was noted that the doctor was attempting to set the valve to 1.0, and the valve had been left in place.It was stated that the patient was doing well and had returned to baseline.The patient should be discharged in a day or two.
Additional Manufacturer Narrative
(b)(6) hospital.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that reported hat the patient returned to the emergency room so the surgeon changed the valve from 1.0 to 1.5.The rep confirmed the settings were updated to 1.5.An x-ray was then performed that also confirmed the results.

• Brand Name: STRATA NSC 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: 6847032
• Report Number: 2021898-2017-00470
• Device Sequence Number: 13468995
• Product Code: JXG
• UDI-Device Identifier: 00643169466111
• UDI-Public: 00643169466111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 12/31/2019
• Device Model Number: 42365
• Device Catalogue Number: 42365
• Device Lot Number: D73367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 84