FDA Adverse Event
Malfunction
Summary report: N
2017865-2008-01368
MDR report key: 1050382
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01368
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- February 12, 2008
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NOISE ON THE ATRIAL LEAD WHICH CAUSED INAPPROPRIATE MODE SWITCHING EPISODES. NOISE WAS NOT APPARENT WITH PULSE GENERATOR INTERROGATION AND CAPTURE AND SENSING THRESHOLDS WERE NORMAL. BIPOLAR ATRIAL IMPEDANCE WAS 545 OHMS AND HAD BEEN STABLE HISTORICALLY. THE LEAD WAS PROGRAMMED TO BIPOLAR SENSE CONFIGURATION AT THE TIME THE NOISE WAS NOTED. THE PHYSICIAN ELECTED TO MONITOR THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DXY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |