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

Model Number	42866
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for valve flux, siphon, reflux, pressure-flow, and pre-implantation testing.The valve did not pass leak testing due to a tear in the delta chamber.There was surface damage to the proximal occluder.It is unknown how or when the damage to the casing occurred.The ifu cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of component.Such damage may lead to loss of shunt integrity¿¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the delta chamber was leaking during the procedure.The valve was replaced and there was no injury to the patient.(b)(6) 2019.
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 because the fluid leakage was found during the implantation process, the same model product was not implanted and replaced in time.According to the surgeon's description, during the implantation process, it was not clear whether there was any device contact with the patient.No additional analysis was performed after the product was removed and sent to the manufacturer.The valve was infiltrated in saline before implantation.It was noted there was no significant effect on the patient.
Additional Manufacturer Narrative
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: 8346184
• Report Number: 2021898-2019-00054
• Device Sequence Number: 13942981
• 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,Followup
• Report Date (Section B): 03/29/2019

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: 02/29/2020
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E30431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 02/19/2019; 03/07/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/06/2019; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 52