MAUDE Adverse Event Report: MECTA CORPORATION MECTA SPECTRUM; ECTDEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Nausea (1970); Blurred Vision (2137); Depression (2361); High Pulmonary Arterial Wedge Pressure (2480); Sleep Dysfunction (2517)

Event Date 08/01/2005

Event Type  Injury  

Manufacturer Narrative

Not possible to followup on the injury report.

Event Description

Patient received 6 ect treatments which were discontinued due to extreme high blood pressure.Many problems after treatments including: panic attacks, severe headaches, weakness on right side of body, extreme insomnia, chest pains, blurry vision, nausea, and major memory loss.

• Brand Name: MECTA SPECTRUM
• Type of Device: ECTDEVICE
• Manufacturer (Section D): MECTA CORPORATION; 19799 sw 95th ave. suite b; tualatin OR 97062
• Manufacturer (Section G): MECTA CORPORATION; 19799 sw 95th avenue suite b; tualatin OR 97062
• Manufacturer Contact: robin nicol ; 19799 sw 95th avenue suite b; tualatin, OR 97062 ; 5036126780
• MDR Report Key: 7294036
• MDR Text Key: 100889084
• Report Number: 3020533-2018-00005
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• PMA/PMN Number: K965070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2006
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability