FDA Adverse Event
Injury
Summary report: N
JK-3 PAIN MANAGEMENT RF GENERATOR
MDR report key: 7928887
·
Received October 2, 2018
Report
- Report Number
- 3002953813-2018-00069
- Event Type
- Injury
- Date Received
- October 2, 2018
- Date of Event
- September 13, 2018
- Report Date
- October 16, 2018
- Manufacturer
- NEUROTHERM, INC
- Product Code
- GXD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BASED ON THE INFORMATION PROVIDED TO ABBOTT THE CAUSE FOR THE REPORTED EVENT WAS DUE TO THE TEMPERATURE BOARD. WHEN THE TEMPERATURE WAS SET 30 DEGREE, THE TEMPERATURE INDICATOR WAS DISPLAYED OVER 35 DEGREE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES.
Description of Event or Problem · 1
DURING THE PROCEDURE, AFTER THE PROBE WAS INSERTED INTO THE PATIENT THE TEMPERATURE INCREASED AND THE INDICATOR LIT UP IN RED. THE PROBE WAS REPLACED BUT THE INDICATOR LIGHT REMAINED IN RED. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767477 | JK-3 PAIN MANAGEMENT RF GENERATOR | GENERATOR, LESION, RADIOFREQUENCY | GXD | NEUROTHERM, INC | JK-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |