MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-S

Device Problem Mechanics Altered (2984)

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

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the valve setting was changing on the patient multiple times. The surgeon noted that they would not be surprised if the patient was ¿messing with it¿ and changed the setting. The valve was explanted and they wanted it analyzed.

Manufacturer Narrative

The returned valve was patent. The valve met the requirements of the reflux, siphon, and valve flux testing. It did not meet the requirements for leak, pressure-flow and preimplantation testing. The valve did not spontaneously change levels during the course of analysis; therefore, the complaint could not be reproduced by the laboratory technicians. The valve did not meet the requirements for leak testing due to a tear/cut in the casing of the delta chamber. There was also damage on the flange. It is unknown how or when this damage occurred. The ifu cautions 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. ¿ there was proteinaceous debris observed on the interior and exterior of the valve. The ifu cautions that, ¿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. ¿ all valves are 100% tested at the time of manufacture. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that it was unknown if the patient had been around sources of magnetic interference.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• 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: 8067032
• MDR Text Key: 127048683
• Report Number: 2021898-2018-00529
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/11/2018

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?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 11/13/2018 Patient Sequence Number: 1