FDA Adverse Event
Malfunction
Summary report: N
SCREW-IN
MDR report key: 2812474
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15695
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- July 1, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K940703
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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 REMOTE MONITOR TRANSMISSION REVEALED ATRIAL HIGH RATE EPISODES AND ONE WAS SUSPENDED BUT DOES NOT APPEAR TO BE ATRIAL FIBRILLATION. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD APPEARS TO HAVE NOISE AND POSSIBLE OVERSENSING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN AND THE ATRIAL HIGH RATE EPISODES AND NOISE COULD NOT BE REPRODUCED IN OFFICE. THE PATIENT'S MEDICATION WAS CHANGED WITH NO OTHER INTERVENTION TAKEN AND THE PATIENT IS DOING FINE. THE ATRIAL LEAD 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 | SCREW-IN | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4558M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other| R | 4024 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR |