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

Model Number UNKNOWN-S

Device Problem Mechanics Altered (2984)

Patient Problems Memory Loss/Impairment (1958); Ambulation Difficulties (2544)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 2019-08-09 (thru patient service): it was reported that shunt/valve was not able to hold the pressure per adjustment.It was reported that three months ago the patient was implanted with medtronic's external pressure regulating shunt tube due to hydrocephalus in the first affiliated hospital of fujian medical university.The postoperative pressure was adjusted to 1.5.On (b)(6) 2019 ct scan of the brain revealed that the ventricles did not become significantly smaller.The patient was unable to walk normally, and the memory was poor.On (b)(6) 2019 the manufacturer personnel adjusted the pressure according to the requirements of the implanted.It was originally prepared to adjust from 1.5 to 1.0, but after the pressure measurement, the pressure was changed to 2.5, and the doctor was advised to adjust to 2.0 and observe for a while.At present, the patient is hospitalized in the affiliated rehabilitation hospital of (b)(6) university of traditional (b)(6) medicine, unable to walk normally, with poor memory.

Event Description

Additional informational was received reported that on august 9, 2019, the patient went to the rehabilitation hospital to review their valve pressure.The pressure was confirmed to be 2.0, and the shunt was working normally.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8879890
• MDR Text Key: 154105059
• Report Number: 2021898-2019-00311
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 71 YR