FDA Adverse Event Injury Summary report: N

ECT DEVICE

MDR report key: 15348826 · Received September 1, 2022

Report

Report Number
MW5111858
Event Type
Injury
Date Received
September 1, 2022
Report Date
August 30, 2022
Manufacturer
UNK
Product Code
QGH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

AS A MANDATED REPORTER, I SUBMIT THIS RECENTLY PUBLISHED ARTICLE ON BEHALF OF THE AUTHORS AS A MORAL OBLIGATION TO CLOSE THE GAP BETWEEN ECT RESEARCH CLINICAL OUTCOMES: "OUR PATIENT IS OLDER, HAD A PAST UNEVENTFUL ECT COURSE, AND HAD ASSOCIATED RESTRICTED DIFFUSION IN HER BILATERAL OCCIPITAL LOBES ON DIFFUSION-WEIGHTED IMAGING (DWI) AFTER HER ECT. FIGURE 1 SHOWS DWI OBTAINED ON A 74-YEAR-OLD WOMAN WHO WAS UNDERGOING A REPEAT COURSE OF ECT AND EMERGED FROM ANESTHESIA REPORTING BLINDNESS. PER THE RADIOLOGIST REPORT, THE IMAGING SHOWS: "MULTIFOCAL SMALL AREAS OF RESTRICTED DIFFUSION IN SUPERFICIAL CORTEX OF BOTH OCCIPITAL LOBES. THESE DO NOT HAVE THE APPEARANCE OF TYPICAL INFARCTS." WE SUSPECT DURING ECT TREATMENT OUR PATIENT EXPERIENCED A HYPERTENSIVE-INDUCED PERIPHERAL VESSEL VASOSPASM IN HER OCCIPITAL CORTEX THAT RESULTED IN HER TRANSIENT CORTICAL BLINDNESS FROM PRES AND THE ABNORMAL RESTRICTED DIFFUSION PATTERN ON IMAGING. TERMINATION OF SEIZURE AND NORMALIZATION OF BLOOD PRESSURE POSTICTALLY MAY HAVE ALLOWED FOR EVENTUAL REVERSIBILITY TO OCCUR RESULTING IN RESOLUTION OF HER SYMPTOMS. TYPICAL IMAGING FINDINGS IN PRES INCLUDE POSTERIOR-CIRCULATION PREDOMINANT WHITE MATTER VASOGENIC EDEMA. HOWEVER, IN SOME MILDER CASES, IMAGING ABNORMALITIES HAVE BEEN SEEN MORE CONSPICUOUSLY IN THE GRAY MATTER, SUGGESTING THAT EDEMA CAN SOMETIMES BEGIN IN THE CORTEX SIMILAR TO OUR PATIENT'S CASE 6 IT IS ALSO TO BE NOTED THAT, ALTHOUGH BOTH PRES AND ACUTE ISCHEMIA CAN DEMONSTRATE HYPERINTENSE SIGNAL ON DWI, ACUTE ISCHEMIA IS MORE LIKELY TO BE UNILATERAL AND CONFINED TO A SINGULAR VASCULAR TERRITORY. THIS DWI INDICATES BILATERAL HYPERINTENSE SIGNALS IN THE POSTERIOR CIRCULATION NOT CONFINED TO A SINGULAR VASCULAR TERRITORY. OUR PATIENT'S SYMPTOMS RESOLVED IN <48 HOURS." FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
273708 ECT DEVICE ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B QGH UNK

Patients

Seq Age Sex Outcome Treatment
1 Female Disability| R| H