FDA Adverse Event Injury Summary report: N

MECTA SPECTRUM 5000Q UNIT

MDR report key: 6294132 · Received January 28, 2017

Report

Report Number
MW5067590
Event Type
Injury
Date Received
January 28, 2017
Date of Event
January 1, 2010
Report Date
January 27, 2017
Manufacturer
MECTA
Product Code
GXC
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THERE ARE A SERIES PATIENTS WITH ADVERSE EVENTS WERE DESCRIBED IN THE ARTICLE: "A SYSTEMATIC REVIEW OF INTERVENTIONS USED TO TREAT CATATONIC SYMPTOMS IN PEOPLE WITH AUTISTIC SPECTRUM DISORDERS" BY HANNAH DEJONG, PENNY BUNTON, AND DOUGAL J. HARE IN JOURNAL. (HIGHLIGHTED ARE 8 SEPARATE EVENTS). THE "ELECTROCONVULSIVE THERAPY ECT INTERVENTIONS" TABLE 1 DESCRIBES ADOLESCENTS EXPERIENCING ADVERSE EVENTS OF WITHDRAWAL, RETINAL DETACHMENT, REOCCURRENCE OF SYMPTOMS AFTER DISCONTINUATION (WHICH INCLUDED EPISODIC EXCITEMENT, RECURRENCE OF SYMPTOMS, AND RELAPSE WITHIN SEVERAL DAYS). ALSO DESCRIBED IS UNSUCCESSFUL TAPERING OF ECT THAT INCLUDED DELIRIUM, RECURRENCE OF SYMPTOMS, "INCREASE IN DEPRESSION, CATATONIA, SELF-INJURY AND AGGRESSION WHEN ECT FREQUENCY REDUCED," AND "ATTEMPTS TO REDUCE ECT WERE UNSUCCESSFUL." THE AUTHOR DESCRIBED THE MECTA SPECTRUM Q, AND MECTA 4000 Q DEVICES USED AND THE ADVERSE EVENT OBSERVED IN THESE PATIENTS AGES 16 - 19. THE AUTHOR NOTED "THE MAJORITY OF STUDIES MADE NO REFERENCE TO ANY ADVERSE EFFECTS OF TREATMENT. THIS IS SURPRISING, GIVEN THE EXTENSIVE LITERATURE THAT EXISTS REGARDING REPORTED SIDE EFFECTS OF ECT..." AUTHOR DESCRIBED PROLONGED SEIZURE IN ZAW ET AL (1999). ZAW 1999 ARTICLE CALLED "CATATONIA, AUTISM, AND ECT" DESCRIBED "ECT WAS GIVEN USING A THYMATRON DGX CONSTANT CURRENT (0.9 A), BRIEF PULSE MACHINE... AT THE FIRST ECT SESSION THE SEIZURE THRESHOLD WAS CALCULATED AT BETWEEN 25 MC TO 50 MC, USING A DOSE TITRATION METHOD. THE INITIAL SEIZURE WAS TERMINATED AT 192 SECONDS WITH INTRAVENOUS DIAZEPAM 10 MG." NO FEEDBACK WAS MADE ON COGNITIVE OR MEMORY EFFECTS AFTER THE PROLONGED SEIZURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
68335 MECTA SPECTRUM 5000Q UNIT MECTA SPECTRUM 5000Q UNIT GXC MECTA
68336 MECTA 4000 Q UNIT MECTA 4000 Q UNIT GXC MECTA
68337 MECTA SPECTRUM ECT DEVICES MECTA SPECTRUM ECT DEVICES GXC MECTA
68338 SOMATICS THYMATRON DGX SOMATICS THYMATRON DGX GXC SOMATICS, INC.

Patients

Seq Age Sex Outcome Treatment
1 Other| S