FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-P
MDR report key: 2812253
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02478
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- October 1, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NVZ
- PMA / PMN Number
- P010015/S084
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DUE TO THE LACK OF AN ATRIAL LEAD, THE IMPLANT DETECT DID NOT COMPLETE, WHICH CAUSED DIAGNOSTIC DATA NOT TO COLLECT. IMPLANT DETECT WAS COMPLETED AND THE DEVICE REMAINS 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 | 69 YR | Required Intervention | 2187 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |