FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3071746
·
Received April 22, 2013
Report
- Report Number
- 2649622-2013-05308
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- March 28, 2008
- Report Date
- February 14, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US 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, DURING THE IMPLANT PROCEDURE, THERE WAS PLACEMENT DIFFICULTY WITH THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT WAS ENROLLED IN THE PANORAMA STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172763 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | (B)(4) IMPLANTABLE PULSE GENERATOR |