FDA Adverse Event Injury Summary report: N

MECTA NOW OWNED BY GORHAM AND ROBIN NICOL

MDR report key: 1571441 · Received January 2, 2010

Report

Report Number
MW5014237
Event Type
Injury
Date Received
January 2, 2010
Date of Event
December 23, 2004
Report Date
January 2, 2010
Manufacturer
MECTA NOW OWNED BY GORHAM AND ROBIN NICOL
Product Code
GXC
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

BILATERAL ELECTROCONVULSIVE THERAPY -ECT- 'TREATMENTS' WERE ADMINISTERED TO ME AS AN INPATIENT FROM 2004 - 2005 -10 'TREATMENTS'- AND AGAIN IN 2005 -9 'TREATMENTS'- AS AN INPATIENT AT THE MEDICAL CENTER. I HAD MAJOR DEPRESSION FOR MANY YEARS AND WAS TREATED WITH DRUGS THAT PRODUCED MINIMAL RESULTS AT BEST AND TOO MANY SIDE EFFECTS. MY DOCTOR SUGGESTED THAT I TRY ECT. DESPITE THE DEPRESSION I WAS A HIGH PERFORMING PROFESSIONAL FOR MANY YEARS AS A CERTIFIED COMPUTER PROJECT MANAGER. I NEVER MISSED A DAY OF WORK DUE TO MY DEPRESSION. PRIOR TO THE ECT, I WAS INFORMED ONLY THAT THERE MIGHT BE 'TRANSIENT' MEMORY LOSS AND THE POSSIBLE EFFECTS OF ANESTHESIA AS A RESULT OF THE ECT. THE RESULTS WERE FAR MORE DEVASTATING. AT FIRST, I WAS IN A STUPOR AND UNAWARE OF THE FAMILY AND FRIENDS WHO VISITED ME IN THE HOSPITAL. I HAVE HAD ONGOING PROBLEMS NOT ONLY WITH THE PERMANENT LOSS OF MANY PAST MEMORIES BUT MY WORKING MEMORY HAS BEEN SERIOUSLY IMPAIRED, AND I HAVE A WIDE VARIETY OF COGNITIVE PROBLEMS, SLOWED THINKING, CONFUSION, ETC.. I ALSO LOST ALMOST 20 POINTS OFF MY IQ. ALL OF THESE IMPAIRMENTS HAVE BEEN DOCUMENTED AND VERIFIED BY BOTH NEUROPSYCHOLOGICAL TESTING AND QEEG TESTING. I TRIED 3XS A WEEK OCCUPATIONAL AND SPEECH THERAPY FOR ALMOST A YEAR WITH LITTLE IMPROVEMENT. DESPITE HAVING DEVELOPED SOME COMPENSATORY STRATEGIES I HAVE BEEN UNABLE TO WORK AND CONTINUE TO FIND DAILY FUNCTIONING DIFFICULT. AFTER REVIEWING MY TEST RESULTS, MY DISABILITY INSURANCE COMPANY, WITHOUT MY ASKING RECLASSIFIED MY DISABILITY FROM MENTAL HEALTH TO A PHYSICAL DISABILITY WHICH INCREASED THE LENGTH OF TIME I WAS ABLE TO RECEIVE BENEFITS FROM THEM. OF COURSE THE HOSPITAL AND ITS DOCTORS DENY THE HARM, AND I HAVE BEEN TOO INCAPACITATED TO SEEK LEGAL RECOURSE. I HAVE SEEN ON THE INTERNET THAT THESE DEVICES ARE UNDER CONSIDERATION TO BE RECLASSIFIED AS CLASS II DEVICES. I AM ASKING THAT THESE ECT DEVICES REMAIN IN CLASS III STATUS AT THE VERY LEAST. PREFERABLY, I THINK THEY SHOULD BE BANNED ALTOGETHER. THEY HAVE NEVER BEEN ACTUALLY PROVEN SAFE AND WERE 'GRANDFATHERED' IN TO CLASS III. MY NEUROLOGIST TOLD ME SHE HAS SEEN MANY PEOPLE AFFECTED AS I HAVE BEEN BY ECT. I SHUDDER TO THINK THAT MANY OTHERS ARE CONTINUOUSLY BEING SUBMITTED TO THIS DANGEROUS AND HARMFUL TREATMENT. I WOULD BE HAPPY TO PROVIDE COPIES OF ALL MY TEST RESULTS AND AM WILLING TO GIVE SWORN TESTIMONY TO THE ABOVE. DOSE OR AMOUNT: UNKNOWN. FREQUENCY: 3 TIMES A WEEK. DATES OF USE: 2004 -- 2005. DIAGNOSIS OR REASON FOR USE: MAJOR DEPRESSION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MECTA NOW OWNED BY GORHAM AND ROBIN NICOL ELECTROSHOCK GXC MECTA NOW OWNED BY GORHAM AND ROBIN NICOL UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 63 YR Required Intervention