FDA Adverse Event
Malfunction
Summary report: N
CAPSUREEPI
MDR report key: 3993952
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09034
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 24, 2014
- Report Date
- June 24, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD DIFFICULTY SEWING ON A SUTURE FIXATION TYPE EPICARDIAL LEAD. THE LEAD WAS REMOVED AND A SCREW-IN FIXATION EPICARDIAL LEAD WAS UTILIZED. IT WAS NOTED THE PATIENT HAD A LOT OF ADIPOSE TISSUE SURROUNDING THE HEART. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470500 | CAPSUREEPI | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4968-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR |