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

Model Number	42365
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the surgeon opened the package, they found that the reservoir was damaged.The valve was not used and was replaced.There was no injury to the patient.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux testing.However, the valve did not meet the requirements for pres sure-flow, pre-implantation, and leak testing due to a tear in the top of the proximal occluder.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also cautions that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, crushing or breaking of components.¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7632780
• Report Number: 2021898-2018-00305
• Device Sequence Number: 13835432
• Product Code: JXG
• UDI-Device Identifier: 00643169975804
• UDI-Public: 00643169975804
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033850
• 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): 10/02/2018

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: 09/30/2022
• Device Model Number: 42365
• Device Catalogue Number: 42365
• Device Lot Number: E39283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 07/06/2018; 08/08/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 07/17/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR