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

Model Number UNKNOWN-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of consciousness (2418)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient was implanted in mid-(b)(6) 2018 due to hydrocephalus.It was stated the patient¿s ventricles were enlarged and the patient was hospitalized.The patient was unable to speak and was unconscious.It was stated the patient was to have a pressure adjustment and would be discharged at the discretion of the doctor.

Manufacturer Narrative

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

Event Description

Additional information received reported that according to the doctor's feedback, the patient's ventricle was not enlarged.The doctor communicated with the patient about a pressure check before discharge, and if there was no pressure change or enlarged ventricle, the patient could be discharged.It was stated the patient wanted to check the pressure one week before leaving the hospital so the patient contacted the manufacturer representative to adjust the pressure privately, but the manufacturer representative did not get the doctor's advice so they refused.After one week of the complaint (the patient's scheduled discharge time), the manufacturer representative and the doctor measured the patient's pressure and found no change.The patient's ventricle was not expanded, and the patient had been discharged smoothly.

• 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: 8165283
• MDR Text Key: 130366926
• Report Number: 2021898-2018-00562
• 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,health profe
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• 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
• Date Manufacturer Received: 01/10/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 26 YR