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

Catalog Number	44465
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that during setup, the physician tried to change the pressure setting from 2.0 to 2.5 but was unable to do so.According to the report, another person tried again, but it didn't work.Reportedly, the device was never implanted, and the procedure was completed with backup products.There was no injury to the patient.
Additional Manufacturer Narrative
Additional information received reported that the manufacturer representative could change the pressure setting of the device.According to the report, the manufacturer representative was to show the doctor.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA LP NSC VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6511761
• Report Number: 2021898-2017-00217
• Device Sequence Number: 767977
• Product Code: JXG
• UDI-Device Identifier: 00643169466210
• UDI-Public: 00643169466210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123524
• 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): 03/23/2017

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 44465
• Device Lot Number: E07497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 06/22/2017; 06/22/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 07/02/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1