FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3152451
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06791
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Report Date
- March 22, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) 2007 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY REMOTE TRANSMISSION THE ATRIAL LEAD HAD UNDERSENSING AND NOISE ON THE BASELINE OF THE ELECTROGRAM. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253064 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4024 IMPLANTABLE PACING LEAD |