MAUDE Adverse Event Report: MECTA CORPORATION MECTA SPECTRUM 5000Q

Model Number SPECTRUM 5000Q

Device Problem Detachment Of Device Component (1104)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 07/11/2007

Event Type  Injury  

Event Description

Presented in part at the distinguished lecture series, (b)(6) institute, (b)(6), (b)(6) 2007.From the (b)(6) institute, the (b)(6) hospital, and the (b)(6) medical center - (b)(6).Article is located here: (b)(6).This is an article of an autistic girl, a serious adverse event is described within the article that should be investigated.Below is the section from the article."modified ect was supervised by (b)(6) and administered with a mecta spectrum 5000q (mecta corporation, tualatin, ore.) unit." "for the first round of ect treatment, before the partial retinal detachment, electrode placement was right unilateral." "unfortunately, after 12 ect treatments, j was found to have a detached left retina from old self-injury before ect.She underwent laser retinal reattachment with oil bubble and scleral buckle procedures, and ect was postponed for 6 weeks due to potential increased intraocular pressure during ect and the risk of oil and suture disruption.Exactly 10 days after her last ect treatment, posturing resumed in j's upper extremities.Full catatonic deterioration ensued rapidly." because of the seriousness of the adverse event, it should be followed-up on and investigated by the manufacturer.There is the issue of the detached retina, but also the deterioration of her state (as in a withdrawal effect) when ect is stopped.I report it directly to the fda, so they are aware of the serious adverse event.I am assuming that the manufacturers conduct publication searches and log any reported adverse events and follow up on them.That may be an assumption, so i report this to you directly.There is also withdrawal adverse events in autism reported here: (b)(6).Not sure how to report to manufacturer.Will have to research online.

• Brand Name: MECTA SPECTRUM 5000Q
• Type of Device: MECTA SPECTRUM 5000Q
• Manufacturer (Section D): MECTA CORPORATION
• MDR Report Key: 5586815
• MDR Text Key: 43031997
• Report Number: MW5061762
• Device Sequence Number: 1
• Product Code: GXC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SPECTRUM 5000Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other