FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2965019
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01904
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- May 1, 2012
- Report Date
- December 13, 2012
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5086MRI IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS REPOSITIONED APPROXIMATELY 7 MONTHS AFTER IMPLANT. THE REASON FOR THE REPOSITIONING IS NOT KNOWN AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE IN PROGRESS. NO PATIENT COMPLICATIONS WERE REPORTED ASA RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67032 | CAPSUREFIX NOVUS MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00039 YR | Required Intervention | RVDR01 IMPLANTABLE PACEMAKER |