FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3152911
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05741
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT ATRIAL (RA) LEAD IMPEDANCE SUDDENLY DROPPED AND THERE WAS NO ELECTROGRAM. THE ANALYZER WAS CHANGED, AND MEASUREMENTS REMAINED THE SAME. IT WAS DETERMINED THAT THE LEAD IMPEDANCE CHANGED WHILE CAUTERY WAS BEING USED. THE RA LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255884 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR |