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

Model Number 42335

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the drainage valve had poor elasticity.The valve was never implanted and there was no injury to the patient.

Manufacturer Narrative

The returned valve was patent.It met the requirements for valve flux, reflux, leak, preimplantation and pressure-flow testing.Therefore, the nature of the complaint could not be replicated by laboratory personnel.There was proteinaceous debris noted within the exterior of the valve.The outlet of the valve was discolored.It is unknown how or when this discoloration occurred.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the valve did not function well and there was no flow though the valve.It was unknown was caused the issue.

• Brand Name: STRATA NSC BURR HOLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8170707
• MDR Text Key: 130541462
• Report Number: 2021898-2018-00566
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169975781
• UDI-Public: 00643169975781
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K082127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 42335
• Device Catalogue Number: 42335
• Device Lot Number: E41986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1