MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA VALVE, NEONATAL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 27219-5

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

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

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that one end of the valve was found to be wobbly instead of rigid.It was noted that this was how the physician remembered the valve to be, rigid on each end so they could get it onto the catheter.

Manufacturer Narrative

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

Event Description

Additional information received reported there was no injury to the patient.The patient's current status was fine.There were no environmental/external/patient factors that may have led or contributed to the issue.

• Brand Name: DELTA VALVE, NEONATAL
• 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: 8434924
• MDR Text Key: 139304333
• Report Number: 2021898-2019-00114
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169507395
• UDI-Public: 00643169507395
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 27219-5
• Device Catalogue Number: 27219-5
• Device Lot Number: E54491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2019
• Date Device Manufactured: 11/09/2018
• 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
• Patient Age: 2 MO
• Patient Weight: 3