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

Model Number 44465

Device Problem Mechanical Jam (2983)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that prior to the procedure, the physician was unable to adjust the valve.This was attempted 5-6 times and the valve was never implanted.A different valve was used to complete the procedure without issue.It was noted that the manufacturer representative was able to adjust the valve, however the valve was still replaced as the physician had experienced issues.

Manufacturer Narrative

The returned valve was returned unopened in the original sterile packaging.Laboratory personnel were able to adjust the valve was adjusted to all performance level settings through the packaging.Therefore, the nature of the complaint could not be replicated by laboratory personnel.The valve was not tested for valve flux, reflux, siphon, leak, pressure-flow, or preimplantation testing as it was not related to the complaint.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 LP 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: 8201158
• MDR Text Key: 131709991
• Report Number: 2021898-2018-00593
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 44465
• Device Catalogue Number: 44465
• Device Lot Number: E42753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• 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