CAPSUREFIX
Report
- Report Number
- 2649622-2013-05854
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- April 4, 2013
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
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).
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THE DEVICE WAS INTERROGATED AND IT WAS DETERMINED THERE WAS OVERSENSING ON THE ATRIAL LEAD. THE SENSITIVITY WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
FURTHER INFORMATION WAS RECEIVED AND INDICATED THERE WAS ANOTHER OCCURRENCE OF ATRIAL LEAD OVERSENSING. THE LEAD SENSING VALUE WAS REPROGRAMMED.
ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS ANOTHER OCCURRENCE OF ATRIAL LEAD OVERSENSING OBSERVED DURING DEVICE INTERROGATION.
ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS ANOTHER OCCURRENCE OF ATRIAL LEAD OVERSENSING OBSERVED DURING DEVICE INTERROGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256016 | CAPSUREFIX | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 4068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |