FDA Adverse Event Injury Summary report: N

3020533-2019-00001

MDR report key: 8437679 · Received March 20, 2019

Report

Report Number: 3020533-2019-00001
Event Type: Injury
Date Received: March 20, 2019
Date of Event: November 17, 2018
Report Date: March 20, 2019
PMA / PMN Number: K965070
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PATIENT IDENTIFIED THE HOSPITAL WHERE ECT TREATMENTS WERE RECEIVED. A REVIEW OF OUR FILES SHOWED THAT THE HOSPITAL PURCHASED A MECTA MODEL D PRIOR TO 1988 WHICH THEY STOPPED USING PRIOR TO 4/18/1990. THE HOSPITAL SWITCHED TO A SOMATICS THYMATRON DEVICE AT THAT TIME, WHICH WE VERIFIED THEY HAVE CONTINUED TO USE THROUGH 2014 AND LIKELY TO THE PRESENT DAY. THE PATIENT'S LAST ECT TREATMENT WAS IN 2009. THUS, AT LEAST THE LAST 19 YEARS OF THE PATIENT'S TREATMENTS WERE NOT DONE WITH A MECTA DEVICE.

Description of Event or Problem · 1

VARIOUS MEDICAL PROBLEMS CLAIMED TO BE CONSEQUENCE OF MORE THAN 80 MAINTENANCE BILATERAL ECT TREATMENTS, INCLUDING: MEMORY LOSS, COGNITIVE IMPAIRMENTS, NEUROLOGICAL PROBLEMS FOLLOWING INFECTIONS. PATIENT SAYS "I NOW HAVE A NEW DEVELOPMENT. ANY TIME I GET MY BACTERIAL, VIRAL OR FUNGAL INFECTION, IT GOES DIRECTLY TO MY BRAIN TRIGGERING PAINFUL DYSTONIA. AIRBORNE PATHOGENS GO DIRECTLY TO MY BRAIN AT TIMES TRIGGERING PAINFUL DYSTONIA, DYSKINESIA-TYPE ERRATIC MOVEMENTS, PARKINSONISM-TYPE GAIT AND MOST RECENTLY DIAPHRAGMATIC PARALYSIS. I BELIEVE THIS IS A DIRECT RESULT OF ECT'S HYPERTENSIVE SURGE BURSTING LESIONS CAUSING BLOOD-BRAIN-BARRIER HYPERPERMEABILITY. ... " "THE DATA LISTED IS MERELY THE MOST RECENT INCIDENT." SUMMARIZING: THE PATIENT COMPLETED ECT IN 2009. SHE IS NOW EXPERIENCING NEUROLOGICAL PROBLEMS FOLLOWING INFECTIONS. SHE BELIEVES THIS TO BE A RESULT OF HER ECT THERAPY. SEE MEDWATCH REPORT MW5081540 FOR FULL DETAILS.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other