FDA Adverse Event
Malfunction
Summary report: N
EXCELLENCE PS+
MDR report key: 4160096
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12038
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 24, 2014
- Report Date
- July 25, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US 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 IMPLANT PROCEDURE THE IMPLANTABLE PACING LEAD (IPL) COULD NOT BE FIXED TIGHTLY. THE IPL WAS EXCHANGED FOR ANOTHER LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638046 | EXCELLENCE PS+ | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | IMK49B58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |