MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-SHUNT KIT, CONTOURED VALVE, REGULAR, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 9003 E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

The product was unavailable for return as it remains implanted.Therefore, an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.(b)(4).

Event Description

It was reported to medtronic neurosurgery that the patient was implanted with a csf shunt kit due to hydrocephalus caused by a cerebellar hemorrhage on (b)(6) 2015.According to the report, the patient's status after surgery was the same as it was before surgery and the patient remained unconscious.It was later reported the patient was doing better and was released from the hospital.

Manufacturer Narrative

The product was unavailable for return as it remains implanted.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.Additional patient/device information: it was later reported that the patient got better after pressing the valve 3~5 times every day according to the doctor's suggestion.Reportedly, the patient has had brain surgery three times and is considering changing the shunt.(b)(4).

Manufacturer Narrative

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

• Brand Name: CSF-SHUNT KIT, CONTOURED VALVE, REGULAR, MEDIUM PRESSURE
• 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: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 5321156
• MDR Text Key: 34850680
• Report Number: 2021898-2015-00486
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K841442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9003 E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 00036 YR