FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 1583160
·
Received January 21, 2010
Report
- Report Number
- MW5014391
- Event Type
- Injury
- Date Received
- January 21, 2010
- Date of Event
- September 1, 2008
- Report Date
- January 21, 2010
- Manufacturer
- UNKNOWN
- Product Code
- GXC
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AK, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
AFTER RECEIVING ECT TREATMENT, PT IMMEDIATELY EXHIBITED SEVERE COGNITIVE IMPAIRMENT, DIFFICULTY SPEAKING, DIFFICULTY WALKING, CAN NO LONGER READ, CONCENTRATE AND CAN NO LONGER WORK. THESE CHANGES SEEM TO HAPPEN OVERNIGHT. PT WAS AN EDUCATED INTELLIGENT, COORDINATED, FULLY FUNCTIONAL MEMBER OF THE COMMUNITY. PT RECEIVED A TOTAL OF 3 TREATMENTS BEFORE TREATMENT WAS HALTED DUE TO CHANGES. TREATMENT DATES (B) (6) - (B) (6). MEDICAL COMMUNITY IS IN DENIAL THAT THIS TREATMENT HAS CAUSED THESE CHANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | ECT | GXC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other |