ECHELON 45
Report
- Report Number
- 3005075853-2010-04639
- Event Type
- Malfunction
- Date Received
- August 16, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).
THE ORCHESTRA PROGRAMMER INVOLVED IN THIS MDR WAS USED TO INTERROGATE AN ICD (OVATIO DR) AFTER THE IMPLANT PROCEDURE. AL THE TESTS WERE PERFORMED (LEAD IMPEDANCE TESTS, RV/SVC CONTINUITY TEST, SENSING TESTS, PACING THRESHOLD TESTS). PT HAS SINUS NODE DYSFUNCTION SO HE WAS PACED CONTINUALLY. THE FOLLOWING EVENTS WERE OBSERVED DURING THE DIFFERENT VENTRICULAR FIBRILLATION INDUCTION PROCEDURES PERFORMED THAT DAY ((B)(6) 2010): OVERALL SLOW BEHAVIOR OF THE PROGRAMMER: SLOW OPERATION, SLOW ACCESS TO THE DIFFERENT SCREENS, SLOW PARAMETERS PROGRAMMING PROCESS, A VERY LONG TIME WAS NECESSARY TO REFRESH THE EPISODES. THE PROGRAMMER SCREEN FROZE COMPLETELY UPON FIRST T-WAVE VF INDUCTION: EVERYTHING WAS GREYED OUT AND ALL BUTTONS WERE INACTIVE; NO ECG WAS AVAILABLE. THE ICD OPERATED NORMALLY (SHOCK ON T-WAVE WAS DELIVERED) ALTHOUGH THE PROGRAMMER WAS STILL FROZEN. DIFFICULT TO SELECT AND PROGRAM DFT PARAMETERS. AT THE END OF THE DIFFERENT PROCEDURES (ALL WERE UNSUCCESSFUL TO INDUCE A VF), THE USER WAS UNABLE TO PROGRAM THE ICD BACK TO ITS PREVIOUS SETTINGS WITH THIS PROGRAMMER. ANOTHER PROGRAMMER WAS USED TO INTERROGATE THE ICD; HOWEVER, NO EPISODE DATED (B)(6) 2010 COULD BE RETRIEVED FROM THE IMPLANT MEMORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 45 | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | G4RY53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ECR45G, F5WM6G |