FDA Adverse Event
Malfunction
Summary report: N
CONSULTA CRT-P
MDR report key: 2791358
·
Received October 15, 2012
Report
- Report Number
- 6000094-2012-02158
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NVZ
- PMA / PMN Number
- P010015/S084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 DATA ANALYSIS FOUND NO ANOMALIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEART FAILURE DIAGNOSTIC MEASUREMENTS WERE NOT BEING DISPLAYED ON THE REMOTE TRANSMISSION. THIS WAS FOUND TO BE AN ABORTED IMPEDANCE VALIDATION FAILURE. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSULTA CRT-P | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC S.A. | C4TR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | 4076 IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD |