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 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the valve was unable to drain during the procedure.The valve was replaced and there was no injury to the patient.

Manufacturer Narrative

The returned valve was patent.It met the requirements for reflux, leak testing, and pressure-flow.It did not meet the requirements for preimplantation testing.There was a suture on the valve flange.There was proteinaceous debris noted within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux and affecting the flow of fluid through the valve.The instructions for use (ifu) that accompany the device cautions that ¿introduction of contaminant could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion.¿ 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
• 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: 8064328
• MDR Text Key: 126954437
• Report Number: 2021898-2018-00525
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00613994380104
• UDI-Public: 00613994380104
• 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
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 42335
• Device Catalogue Number: 42335
• Device Lot Number: E20129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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
• Patient Age: 83 YR