FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4832127
·
Received June 10, 2015
Report
- Report Number
- 3008973940-2015-00228
- Event Type
- Injury
- Date Received
- June 10, 2015
- Date of Event
- October 12, 2014
- Report Date
- April 14, 2015
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS RE-POSITIONED DUE TO HIGH AND/OR UNSTABLE THRESHOLDS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE REVEAL AF CLINICAL STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374766 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC SINGAPORE OPERATIONS | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Hospitalization| R | EN1DR01 IPG, 5076-52 LEAD |