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

Model Number 42856

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/27/2018

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 malfunctioned during the procedure.It was stated that valve had an issue priming.The procedure was completed using another valve which worked properly.There was no patient impact.

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 have patient contact.It was stated the valve did not function properly and there were no "out of the ordinary situational issues" that could be identified that would contribute to the reported issue.

Manufacturer Narrative

The returned valve was patent.The valve met the requirements for valve flux, siphon, reflux, pressure-flow, pre-implantation, and leak testing.The laboratory personnel were able to adjust the valve normally.Therefore, the nature of the complaint could not be replicated by laboratory personnel.Particulates were observed on the interior and exterior of the valve.It is not known how or when these particulates entered the valve.The instructions for use cautions that, ¿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 overdrainage.¿ base misalignment was observed in the reservoir.It is unknown how or when this damage occurred.The instructions for use cautions, ¿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¿¿ 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 II VALVE, SMALL
• 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: 8171483
• MDR Text Key: 130626585
• Report Number: 2021898-2018-00568
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169975828
• UDI-Public: 00643169975828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2019

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: 07/31/2020
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: E36957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 5 MO