FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 2951491
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00115
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 4, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. CONCOMITANT DEVICES: 6947 IMPLANTABLE HIGH VOLTAGE LEAD, 2007 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY REMOTE TRANSMISSION, THERE WAS UNDER SENSING ON THE ATRIAL LEAD. THE LEAD REMAINS IMPLANTED HOWEVER THE DEVICE IS PROGRAMMED NOT TO UTILIZE THIS LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56536 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |