NA
Report
- Report Number
- 3006630150-2024-05263
- Event Type
- Malfunction
- Date Received
- August 12, 2024
- Date of Event
- July 17, 2024
- Report Date
- December 31, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- GXD
- UDI-DI
- 00813250010107
- PMA / PMN Number
- K050084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: GXD, GXI.
DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE REVEALED THAT IT WOULD NOT REGISTER TEMPERATURE DURING FUNCTIONAL TESTING. AN X-RAY INSPECTION CONFIRMED THAT A FRACTURED WIRE IN THE HUB CAUSED AN OPEN CIRCUIT. THIS DAMAGE IS INDICATIVE OF FATIGUE FROM OVERUSE OF THE ELECTRODE. A LABELING REVIEW WAS CONDUCTED WHICH DETERMINED THAT THE ELECTRODE SHOULD NOT BE SHARPLY BENT, AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). THEREFORE, ENGINEERS CONCLUDED THAT THIS DAMAGE TO THE ELECTRODE WAS DUE TO THE DEVICE DESIGN. B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. D2B: GXD, GXI.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOT NUMBER WAS PREVIOUSLY INCORRECT AND A DIFFERENT LOT NUMBER WAS CONFIRMED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOT NUMBER WAS PREVIOUSLY INCORRECT AND A DIFFERENT LOT NUMBER WAS CONFIRMED. AFTER FURTHER REVIEW, THE BROKEN ELECTRODE WAS DISCOVERED POST-PROCEDURE AND DID NOT OCCUR INSIDE THE PATIENT. AS SUCH, THERE WAS NO REPORTED PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2216674 | NA | GENERATOR, LESION, RADIOFREQUENCY | GXD | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | CSK-TC10 | 31309592 | 00813250010107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |