CONSULTA
Report
- Report Number
- 6000144-2011-00680
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE DEVICE IS FUNCTIONING AS INTENDED. THE LV (LEFT VENTRICULAR) CAPTURE MANAGEMENT IS NOT DESIGNED TO WORK WHEN THERE IS A COMPETING RHYTHM THAT IS BEING SENSED BY THE DEVICE. IN THIS CASE THE COMPETING RHYTHM IS THE PATIENT'S CURRENT HEART RATE.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE DEVICE WAS NOT RUNNING LEFT VENTRICULAR (LV) CAPTURE MANAGEMENT FOR THE WEEK PRIOR. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE DEVICE WAS NOT RUNNING LEFT VENTRICULAR (LV) CAPTURE MANAGEMENT FOR THE WEEK PRIOR. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSULTA | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other | (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| 0158 COMPETITOR IMPLANTABLE TACHY LEAD| 4543 COMPETITOR IMPLANTABLE PACING LEAD |