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

Model Number UNKNOWN-S

Device Problem Insufficient Information (3190)

Patient Problem Dysphasia (2195)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Event date is an approximation.Initial reporter is the patient.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient was implanted in 2008 due to hydrocephalus.It was stated that in (b)(6) 2018, the patient began to have unclear articulation and reportedly pressed the reservoir on their own.They found that the reservoir was rebounding slowly.The doctor told the patient not to press the reservoir on their own.It was noted the patient was at home with a slurred condition.

Manufacturer Narrative

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

Event Description

Additional information received reported that it was unsure if there was a device malfunction.It was recommended to go to the hospital for a detailed inspection.No additional action was taken to resolve the patient's articulation due to they had no symptoms and did not need pressure regulation.It was also recommended that the patient visit the hospital regularly according to the doctor's advice.The patient did not currently have any discomfort.

• 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
• 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: 8137749
• MDR Text Key: 129574896
• Report Number: 2021898-2018-00548
• 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,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR