FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2791220
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14507
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- April 3, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD WAS OVERSENSING, UNDERSENSING AND HAD LOW P-WAVES. THE DEVICE WAS SAFETY PACING AND CAUSING THE PATIENT TO COMPLAIN OF NOT FEELING WELL WITH THE VENTRICULAR PACES. THE SAFETY PACING WAS PROGRAMMED OFF AND BOTH LEADS REMAIN IN USE. THE PATIENT WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS MRI | IMPLANTABLE PACING LEAD | NVN | MEDTRONIC PUERTO RICO, INC. | 5086MRI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | RVDR01 IMPLANTABLE PULSE GENERATOR |