FDA Adverse Event
Malfunction
Summary report: N
CRYSTALLINE ACTIVE FIXATION
MDR report key: 3990384
·
Received August 7, 2014
Report
- Report Number
- 2649622-2014-08699
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Date of Event
- May 20, 2014
- Report Date
- May 22, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEAD COULD NOT BE FIXED IN THE TARGET POSITION. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464195 | CRYSTALLINE ACTIVE FIXATION | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | ICQ09B58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR |