FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 3152937
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05742
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 8, 2013
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
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): PRODUCT ID 457453, IMPLANTABLE PACING LEAD, 2013-(B)(6), (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD WAS INTERMITTENTLY PACING AND WAS OVERSENSING. THE SENSITIVITY WAS REPROGRAMMED. THE LEADIS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258046 | CAPSUREFIX NOVUS MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | A3DR01 IMPLANTABLE PULSE GENERATOR |