Model Number MECTA SIGMA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Chest Pain (1776); Headache (1880); Pain (1994); Fecal Incontinence (4571)
|
Event Date 06/23/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
This complaint was from a medwatch report filed by a patient.According to the doctors, the mecta sigma device was working as expected to patients before, during and after the jeremy's ect treatments.The device passes all exhaustive internal start up and after treatment internal tests.Interview with the doctor disclosed the following: - the device worked very well, just as expected.- they tell all of their patients to not eat after midnight the night before and to empty their bowels in the morning before treatment.- very few patients can lose control of their bowels, but it can happen.
|
|
Event Description
|
Patient was recommended for ect (electroconvulsive therapy) treatment.The patient reports the following: 1) they had a severe headache post treatment and was given tramadol.2) they had fecal incontinence, pain up and down back and neck, and chest pain.Note: the patient has had their neck fused, herniated disc problems and other spinal issues in the past that is unrelated to the ect treatment.
|
|
Manufacturer Narrative
|
This complaint was from a medwatch report filed by a patient.According to the doctors, the mecta sigma device was working as expected to patients before, during and after the jeremy's ect treatments.The device passes all exhaustive internal start up and after treatment internal tests.Interview with the doctor disclosed the following: the device worked very well, just as expected.They tell all of their patients to not eat after midnight the night before and to empty their bowels in the morning before treatment.Very few patients can lose control of their bowels, but it can happen.Follow up report: new information has not been added or has become available.The original report is unaltered.Therefore, there is no changes to the event, the investigation, or the conclusion.The follow up is that the initial reporter has updated their contact information and has asked to remain confidential.Therefore, we have removed their contact information from our report.The original report had the wrong device product code.This has been corrected from gxc to qgh.
|
|
Event Description
|
Patient was recommended for ect (electroconvulsive therapy) treatment.The patient reports the following: they had a severe headache post treatment and was given tramadol.They had fecal incontinence, pain up and down back and neck, and chest pain.Note: the patient has had their neck fused, herniated disc problems and other spinal issues in the past that is unrelated to the ect treatment.
|
|
Search Alerts/Recalls
|
|