FDA Adverse Event
Injury
Summary report: N
INTELECT XT 4CH COMBO
MDR report key: 1161195
·
Received September 15, 2008
Report
- Report Number
- 1022819-2008-00275
- Event Type
- Injury
- Date Received
- September 15, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 8, 2008
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- IMG
- PMA / PMN Number
- K031077
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CLINIC WAS CONTACTED BY CUSTOMER SERVICE. THE CLINIC INFORMED CHATTANOOGA GROUP THAT THEY PREFER NOT TO BE CONTACTED ANY MORE REGARDING THIS MATTER. THE CLINIC DID NOT RETURN THE FORM 104 INVESTIGATION SHEET. THE DEVICE HAS BEEN RECEIVED, AND IS CURRENTLY UNDER EVAL. THE DEVICE EVAL AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVAL.
Description of Event or Problem · 1
THE ELECTROTHERAPY DEVICE PRODUCED A STIM BOARD ERROR 301 AND A PT WAS BURNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT XT 4CH COMBO | IMG; GZI, GZJ, IPF | IMG | CHATTANOOGA GROUP | 2760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |