FDA Adverse Event
Injury
Summary report: N
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
MDR report key: 3050955
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04793
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. (B)(4): 5086 IMPLANTABLE PACING LEAD 2012-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT IT WAS THOUGHT THAT SOME OF THE SUPRA-VENTRICULAR TACHYCARDIA (SVT) HIGH RATE EPISODES MAY BE DUE TO FAR-FIELDRWAVE OVERSENSING ON THE ATRIAL LEAD. PARTIAL POST-VENTRICULAR ATRIAL BLANKING (PVAB) AND MANAGED VENTRICULAR PACING (MVP) MODE WERE PROGRAMMED ON AND THE PATIENT IS CONDUCTING. THE LEAD REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 148911 | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Required Intervention | RVDR01 IMPLANTABLE PACEMAKER |