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

Model Number	42866
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fever (1858)
Date of Event	04/07/2019
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
Information was received regarding a patient undergoing cerebral peritoneal shunt surgery due to traumatic brain injury.It was reported that the patient had a continuous fever that occurred one week after surgery and did not improve.As there was a risk of infection, the device was removed.After the patient returned to normal another surgery was completed.There was no product damage.There were no related patient symptoms.Additional information received reported that no adjustment was done anytime after implantation.No activities/analyses were done on the valve after the removal from the patient prior to sending it to the manufacturer.The valve was not bathed in any chemicals or antibiotics prior to implantation.No mri's were performed while the device was implanted.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for valve flux, reflux and siphon testing.The catheter from (b)(4) was connected to the valve with a suture.The valve did not meet the requirements for leak testing due to a tear in the reservoir.It is unknown how or when this damage occurred.The instruction for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity¿¿ the valve did not meet the requirements for pressure flow and preimplantation testing due to proteinaceous debris on the interior of the valve.Proteinaceous debris was also observed on the exterior of the valve.The instructions for use cautions, ¿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 II 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: 8562406
• Report Number: 2021898-2019-00166
• Device Sequence Number: 11147436
• Product Code: JXG
• UDI-Device Identifier: 00613994804648
• UDI-Public: 00613994804648
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E19352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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