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

Model Number UNKNOWN-S

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that the patient was implanted with a shunt on (b)(6) 2016 and there was no pressure adjustment after surgery.The patient was admitted to a neurological hospital on "(b)(6) 2016" for inpatient treatment.It was also noted that the "patient showed obvious depression in [their] head" when they were sitting up in the hospital and began experiencing tremors.The symptoms would improve when the patient was lying down.A ct scan was performed and the health care provider (hcp) indicated that the previously noted symptoms resulted from excessive drainage.A pressure regulation was needed; however, the hospital did not have the tool needed to perform the pressure regulation.It was noted that the event began occurring in (b)(6) 2017; however, this information conflicts with the previously noted report.Follow-up is being conducted to obtain clarification regarding this discrepant information.

• 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: 7053682
• MDR Text Key: 92789725
• Report Number: 2021898-2017-00587
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 75 YR