FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3071795
·
Received April 22, 2013
Report
- Report Number
- 2649622-2013-05278
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- February 25, 2013
- 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
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 6947 IMPLANTABLE DEFIB LEAD (B)(6) 2010; 6725 LEAD ADAPTOR (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD POSITION HAD FAILED. AN ATRIAL LEAD REPOSITION WILL BE DISCUSSED WITH THE CARDIOLOGIST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171086 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00037 YR | D224TRK IMPLANTABLE BIV DEFIBRILLATOR |