MAUDE Adverse Event Report: MECTA CORPORATION MECTA SPECTRUM 5000Q; ECTDEVICE

Model Number SPECTRUM 5000 Q

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Memory Loss/Impairment (1958); Depression (2361)

Event Date 12/20/1999

Event Type  Injury  

Manufacturer Narrative

Not possible to followup on the injury report.

Event Description

Severe amnesia following ect treatments from (b)(6) for depression.Remains disabled after 10 years.

• Brand Name: MECTA SPECTRUM 5000Q
• 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: 7294038
• MDR Text Key: 100888774
• Report Number: 3020533-2018-00001
• 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

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
• Device Model Number: SPECTRUM 5000 Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• 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