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

Model Number SPECTRUM 5000 Q

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Depression (2361)

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2016 email from distributor notifying us of death by myocardial infarction two hours after ect treatment.On (b)(6) 2016 our quality manager responded with a series of questions about the event and the device used.Received no response.On (b)(6) 2016 our international manager requested the answers to the questions previously sent.On (b)(6) 2016 our distributor responded and said he had been on vacation, and he now needed to talk with others before he could answer the questions.On (b)(6) 2016 our international manager again requested response.On (b)(6) 2016 our international manager emailed the distributor again and sent a copy of the distributor agreement along with an adverse event form to be filled out an returned.We have received no further responses from our distributor.

Event Description

A patient died of cardiac arrest 2 hours after receiving an ect treatement at (b)(6) hospital.

• 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: 7294040
• MDR Text Key: 100887267
• Report Number: 3020533-2018-00014
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K965070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: 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
• Device Model Number: SPECTRUM 5000 Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2016
• 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): Death