FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-P
MDR report key: 2811677
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02550
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- October 5, 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
- IA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 THE SENSING TEST WAS UNABLE TO BE PERFORMED. THE PACING SYSTEM DID NOT HAVE AN ATRIAL LEAD AND IMPLANT DETECT DID NOT COMPLETE. IMPLANT DETECTED WAS TURNED OFF. THE DEVICE REMAINS 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 CRT-P | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC S.A. | C4TR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | 1388T COMPETITOR IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD |