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

Model Number 46866

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during testing prior to implant, the delta chamber was found to be leaking from the distal end.The product was replaced.

• Brand Name: STRATA II SHUNT ASSEMBLY, REGULAR
• 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: 8071361
• MDR Text Key: 127368498
• Report Number: 2021898-2018-00533
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169975965
• UDI-Public: 00643169975965
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 46866
• Device Catalogue Number: 46866
• Device Lot Number: E48887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2018
• Date Device Manufactured: 07/14/2018
• 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