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

Model Number 42856

Device Problem Mechanical Jam (2983)

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

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the nurse was attempting to adjust the valve with the handtools prior to opening the package, but the valve would not adjust past level 1.0.Multiple attempts were made to no avail.A different valve was used andworked fine.

Manufacturer Narrative

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

Event Description

Additional information received reported that the valve was not adjusted on a metal table.Alignment was maintained between the adjustment tool and valve setting when the distance between the two was less than 15cm.When the pressure level was checked, the adjustment tool was at least 76cm away from the valve.

Manufacturer Narrative

The returned valve was not removed from the sealed sterile tyvek pouch.Laboratory personnel were able to adjust the performance level settings from 0.5 to 2.5 then down to 0.5 again though the packaging.Therefore, the nature of the complaint could not be replicated.Due to the nature of the complaint the valve was not tested for patency, leak, reflux, siphon, valve flux, pressure-flow and preimplantation.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: 8066944
• MDR Text Key: 127066742
• Report Number: 2021898-2018-00528
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169975828
• UDI-Public: 00643169975828
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042465
• 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,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: E41721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 01/13/2019; 02/27/2019
• Supplement Dates FDA Received: 02/08/2019; 03/01/2019
• 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: Initial
• Patient Sequence Number: 1