FDA Adverse Event
Malfunction
Summary report: N
AV PLUS DX BIFURCATED BIPOLAR
MDR report key: 2240387
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05453
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- July 20, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INCREASED ATRIAL THRESHOLD. ATRIAL IMPEDANCE HAD DECREASED FROM 519 OHMS TO 205 OHMS. THE LEAD WOULD BE REVIEWED AGAIN IN ONE MONTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AV PLUS DX BIFURCATED BIPOLAR | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1368/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |