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 Coma (2417); Convulsion/Seizure (4406)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that in 2019, the patient was implanted with an adjustable pressure shunt due to hydrocephalus.On (b)(6) 2021, the patient had an intensive mri examination in the operating hospital.The pressure measurement/pressure adjustment was not performed after the mri examination.On (b)(6) 2021, symptoms of convulsions and coma appeared after the patient arrived home.The patient had a pressure measurement/adjustment at the local hospital; however, the symptoms did not improve.The neurosurgeon arranged for the pressure to be adjusted from 2.5 to 2.0, a total of 3 adjustments.After the first 2 pressure adjustments, it would automatically jump to 2.5.As this situation hadn't been encountered before at the local hospital, it was recommended that the patient return to the operating hospital for review.At present, the patient was on their way to the hospital for pressure adjustment; however, as the surgeon was on a business trip, the family would call the outpatient number, and if the patient felt unwell, they would go to the emergency department.Currently, the patient was in good condition and had recovered consciousness without discomfort.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11871188
• MDR Text Key: 252210831
• Report Number: 2021898-2021-00116
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• 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: 05/20/2021
• 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
• Patient Age: 40 YR