FDA Adverse Event
Injury
Summary report: N
4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR
MDR report key: 7143207
·
Received December 22, 2017
Report
- Report Number
- 3002953813-2017-00060
- Event Type
- Injury
- Date Received
- December 22, 2017
- Date of Event
- November 29, 2017
- Report Date
- February 9, 2018
- Manufacturer
- NEUROTHERM, INC
- Product Code
- GXD
- PMA / PMN Number
- K111576
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE FIELD REPORTED EVENT OF FAILURE TO START UP WAS CONFIRMED AS THE GENERATOR WOULD NOT BOOT AND DISPLAYED A WHITE SCREEN DURING THE EVALUATION. THE GENERATOR WAS CONNECTED TO AN EXTERNAL MONITOR AND A CHECKSUM ERROR APPEARED. THE REPORTED FAILURE TO START UP WAS CONFIRMED. THE ROOT CAUSE WAS ISOLATED TO A DEPLETED CMOS BATTERY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.
Description of Event or Problem · 1
DURING AN ABLATION PROCEDURE, THE GENERATOR BOOTED TO A WHITE SCREEN AND WOULD NOT BOOT UP. MULTIPLE REBOOTS WERE PERFORMED WITH NO RESOLUTION. THE PROCEDURE WAS CANCELLED. THERE WERE NO KNOWN PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 922612 | 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR | GENERATOR, LESION, RADIOFREQUENCY | GXD | NEUROTHERM, INC | RFG-NT-2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |