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 Problems Therapeutic Effects, Unexpected (2099); Dysphasia (2195); Loss of consciousness (2418)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received via a health care professional regarding a patient implanted with an external pressure regulating shunt about 3 years ago.It was stated the patient had poor drainage due to hydrocephalus.The patient's postoperative pressure was adjusted to 1.0 in (b)(6) 2016, and the ventricular enlargement did not improve significantly.The surgeon indicated that there was no other way to improve it with it unclear why the patient experienced the issue.The doctor recommended that the patient press the valve daily to speed up the flow rate.In (b)(6) 2018 the patient was implanted with a lumbar cistern shunt, showing postoperative ventricular enlargement improvement.The pressure position at this time was 0.5.In (b)(6) 2019 the patient was unable to speak, unconscious, unable to act, with them ultimately hospitalized on (b)(6).The physician noted the rebound of the ventricle valve was slow after the valve end was pressed, with it suspected that the ventricle valve was unusable.As a result it was required that an mri be taken.And active cooperation will be done with the doctor.

• 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: 8838283
• MDR Text Key: 152547545
• Report Number: 2021898-2019-00300
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• 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: 07/09/2019
• 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): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 60