FDA Adverse Event
Malfunction
Summary report: N
CONSULTA
MDR report key: 1864848
·
Received October 12, 2010
Report
- Report Number
- 6000144-2010-05145
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 DEVICE RECORDED AN ATRIAL FIBRILLATION (AF) EPISODE WITH RAPID VENTRICULAR RATE (RVR). THE PATIENT HAS NO ATRIAL LEAD AND INTERROGATION OF DEVICE SHOWS PR LOGIC IS ON. 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 | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other | 6932 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD |