FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3152302
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06871
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH 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 PRODUCTS: 850 COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 1984. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ATRIAL LEAD WARNING TRIPPED THE SAME DAY THE PATIENT HAD HEART VALVE SURGERY. WEEKS LATER, THE LEAD WAS PACING AND SENSING APPROPRIATELY WITH GOOD IMPEDANCES. IT WAS NOTED THAT THE DEVICE WAS A UNIPOLAR-DEDICATED DEVICE. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252832 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00046 YR | (B)(4) IMPLANTABLE PULSE GENERATOR |