MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SM EXTRACTED, PERFORMANCE LEVEL 1.5; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 27554-5

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the patient had a reaction to their implant.It was stated the patient had been experiencing irritation with their tubing/valve.They were tested for allergies, and xylene was found as an allergen for them.

• Brand Name: DELTA SM EXTRACTED, PERFORMANCE LEVEL 1.5
• 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 ; 7635263305
• MDR Report Key: 9508146
• MDR Text Key: 190554009
• Report Number: 2021898-2019-00459
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169483149
• UDI-Public: 00643169483149
• 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
• Report Date: 12/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 27554-5
• Device Catalogue Number: 27554-5
• Device Lot Number: E22644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Date Device Manufactured: 11/15/2016
• 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: 19 YR
• Patient Weight: 88