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

Model Number	42335
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2018
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 that the drainage valve had poor elasticity and a slow rebound.There were no symptoms associated with the event.The valve was explanted, and the patient's status at the time fo the report was alive-no injury.
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 environmental/ external/patient factors identified that may have led or contributed to the issue.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux and valve flux testing.However, it did not meet the requirements for leak testing, pressure-flow and preimplantation testing.The leak testing did not meet requirements due to a cut on the distal occluder.It is unknown how or when this damage occurred.The instructions for use (ifu) caution that ¿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 and necessitate premature surgical revision of the shunt system.¿ proteinaceous debris was also observed on the exterior and interior of the valve.The ifu cautions ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion or may also hold pressure/flow controlling mechanisms open, resulting in over drainage.¿ 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 BURR HOLE VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7991267
• Report Number: 2021898-2018-00505
• Device Sequence Number: 1399443
• Product Code: JXG
• UDI-Device Identifier: 00643169975781
• UDI-Public: 00643169975781
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K082127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2018

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: 07/31/2022
• Device Model Number: 42335
• Device Catalogue Number: 42335
• Device Lot Number: E35710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/22/2018; 11/30/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 10/31/2018; 12/28/2018
• 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