FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3051193
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04821
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Report Date
- December 23, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 DEVICE: 5076 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT UNDER SENSING WAS NOTED ON THE ATRIAL LEAD. THE LEAD WAS CAPPED REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149137 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | P1501DR IMPLANTABLE PULSE GENERATOR (IPG) |