FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3862370
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06956
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- February 28, 2013
- Report Date
- March 14, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. CONCOMITANT PRODUCTS: 837217 CRT-D IMPLANTED: (B)(6) 2013; LINOX S65 LEAD IMPLANTED: (B)(6) 2013. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A COMPARISON OF THE USE BEFORE DATE FIELD AND IMPLANT DATE FOUND THE RIGHT ATRIAL (RA) LEAD WAS IMPLANTED AFTER THE USE BEFORE DATE. THE LEAD REMAINS IN USE. THE PATIENT WAS ENROLLED IN THE MARC CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338478 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR | 429888 LEAD |