FDA Adverse Event
Injury
Summary report: N
INTELECT MOBILE 2CH STIM
MDR report key: 1180208
·
Received September 29, 2008
Report
- Report Number
- 1022819-2008-00215
- Event Type
- Injury
- Date Received
- September 29, 2008
- Date of Event
- April 19, 2007
- Report Date
- April 19, 2007
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- IPF
- Removal / Correction Number
- 1022819-11/15/2007-001-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS FOR EXPORT ONLY.
Description of Event or Problem · 1
PT COMPLAINED OF SHOCK DURING MUSCLE STIMULATION. THE RESULTANT SHOCK CAUSED THE PT TO FLINCH, INCURRING A CUT THAT REQUIRED SUTURES. THIS MALFUNCTION CAUSES THE PRINTED CIRCUIT BOARD TO CHANGE THE STIMULATORY PT OUTPUT FROM THE INTENDED OUTPUT TO A UNINTENDED HIGHER VOLTAGE OUTPUT. WHEN SUCH A MALFUNCTION OCCURS, IT RESULTS IN A SHOCK SENSATION AND POSSIBLE BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT MOBILE 2CH STIM | IPF, GZJ, GZI | IPF | CHATTANOOGA GROUP | 2777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |