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

Model Number	42856
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8066944
• Report Number: 2021898-2018-00528
• Device Sequence Number: 13941355
• Product Code: JXG
• UDI-Device Identifier: 00643169975828
• UDI-Public: 00643169975828
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 01/13/2019; 02/27/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 02/08/2019; 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1