FDA Adverse Event
Injury
Summary report: N
SELECTSECURE
MDR report key: 3994270
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-10101
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- December 31, 2008
- Report Date
- February 13, 2009
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P030036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR 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 THE PATIENT EXPERIENCED A ¿COLLAPSE¿. AN X-RAY PERFORMED IN THE CLINIC SHOWED THAT THE LEAD WAS NOT IN PLACE. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS ENROLLED IN THE PROTECT-PACE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472142 | SELECTSECURE | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 383069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Hospitalization| R |