FDA Adverse Event Injury Summary report: N

SOMATICS

MDR report key: 1981163 · Received February 2, 2011

Report

Report Number
MW5019271
Event Type
Injury
Date Received
February 2, 2011
Date of Event
August 12, 2006
Report Date
February 2, 2011
Manufacturer
SOMATICS
Product Code
GXC
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AFTER THE PATIENT WAS GIVEN 6 SESSIONS OF ECT OVER A TWO MONTH PERIOD, SHE BECAME CONFUSED AND DISORIENTED. HER ORIGINAL PROBLEM WAS SEVERE DEPRESSION, BUT SHE BEGAN TO HAVE SIGNS OF MEMORY LOSS. SHE CLAIMED SHE NO LONGER REMEMBERS MEETING HER HUSBAND OR HER WEDDING DAY. SHE COULDN'T REMEMBER THE NAME OF HER CHILDHOOD DOG. SHE WAS VERY INTERESTED IN PHYSICS AND FOUND SHE COULDN'T REMEMBER THE MOST RUDIMENTARY FORMULAS. SHE REPORTED EXPERIENCING SPEECH ABNORMALITIES. IT DID SEEM THAT SHE WAS SPEAKING A FEW WORDS IN SHORT BURSTS WITH UNUSUALLY LONG PAUSES IN BETWEEN. AFTER SIX MONTHS, SHE WAS ABLE TO TALK AND FUNCTION BETTER, BUT SHE CLAIMS SHE DID NOT RECOVER HER MEMORIES. SINCE THE ECT, SHE HAS NOT BEEN ABLE TO WORK, AND SHE WAS PREVIOUSLY EMPLOYED FOR FIVE YEARS BEFORE THE TREATMENT. SHE REPORTS A LOWER QUALITY OF LIFE AND SHE DOES NOT FEEL LIKE HERSELF. SHE STILL SUFFERS FROM CHRONIC DEPRESSION. THE THYMATRON MAKERS STATE ON THEIR WEBSITE AND IN BROCHURES GIVEN TO THE ADMINISTERING PHYSICIAN THAT IT CAN CAUSE LOSS OF RECENT AND REMOTE MEMORIES. HOWEVER, IT DID NOT CLAIM THAT THIS COULD LEAD TO EXACERBATING THE DISABILITY OF THE PATIENT. SHE WENT FROM WORKING AND GOING TO NIGHT SCHOOL TO NEEDING HELP WITH EVERYDAY LIVING. HER DEPRESSION WORSENED AFTER THE TREATMENT DUE TO A FEELING OF LOSS. A LOSS OF HER MEMORIES, KNOWLEDGE, AND SKILL SETS. NOW SHE REPORTS THE TYPE OF CHRONIC DEPRESSION SHE SUFFERED HER WHOLE LIFE, LIKELY BECAUSE OF PTSD. THE DEVICE DID NOT HELP THE PATIENT, BUT MADE HER HANDICAPPED. SHE CAN NO LONGER LIVE ALONE AND ALSO HAS A SERVICE DOG TO COMFORT HER AND REMIND HER WHEN TO TAKE HER MEDICATIONS. DOSE OR AMOUNT: PULSEWIDTH 3 SECONDS 3 TRAINS, FREQUENCY: WEEKLY. DATES OF USE: (B)(6) 2006 AND (B)(6) 2006. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SOMATICS THYMATRON SYSTEM IV GXC SOMATICS SYSTEM IV

Patients

Seq Age Sex Outcome Treatment
1 24 YR Other| R