FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIXNOVUS
MDR report key: 2951902
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00289
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 13, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, 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. PRODUCT: 4196 IMPLANTABLE PACING LEAD (B)(6) 2012; 6949 IMPLANTABLE TACHY LEAD (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY REMOTE TRANSMISSION THERE WAS UNDER SENSING ON THE ATRIAL LEAD FOUND ON THE ELECTROGRAMS. 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 |
|---|---|---|---|---|---|---|---|
| 56083 | CAPSUREFIXNOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |