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

Model Number 42836

Device Problem Mechanics Altered (2984)

Patient Problems Loss of consciousness (2418); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's shunt had been turning off and on, on its own.It was clarified that the settings had been changing.The patient had been experiencing issues with their balance and gait.They had also experienced some passing out as well.

• Brand Name: STRATA BURR HOLE VALVE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9801325
• MDR Text Key: 189669762
• Report Number: 2021898-2020-00089
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00613994380098
• UDI-Public: 00613994380098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 42836
• Device Catalogue Number: 42836
• Device Lot Number: D63155
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Date Device Manufactured: 07/31/2014
• 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
• Patient Outcome(s): Other