MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	27819
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2016
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.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the cerebrospinal fluid did not flow normally with setting pressure prior to use.According to the report, the device was replaced with a new device to complete the surgery and there was no patient impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SHUNT ASSEMBLY, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6179635
• Report Number: 2021898-2016-00478
• Device Sequence Number: 1025573
• Product Code: JXG
• UDI-Device Identifier: 00643169010499
• UDI-Public: 00643169010499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/17/2016

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: 12/31/2018
• Device Catalogue Number: 27819
• Device Lot Number: E09184
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1