FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2790659
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14757
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- August 14, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 AT IMPLANT THE THRESHOLDS ON THE RIGHT VENTRICULAR LEAD WERE APPROPRIATE, BUT THE NEXT DAY THE CAPTURE WAS INTERMITTENT. THE LEAD WAS SCHEDULED TO BE REPOSITIONED BUT THIS WAS NOT DONE BECAUSE THRESHOLDS HAD IMPROVED. HOWEVER, A WEEK LATER AT THE CLINIC THE THRESHOLD HAD INCREASED AGAIN. THE PATIENT WILL FOLLOW UP IN TWO WEEKS. 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 |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS MRI | IMPLANTABLE PACING LEAD | NVN | MEDTRONIC PUERTO RICO, INC. | 5086MRI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | 5086MRI IMPLANTABLE PACING LEAD| RVDR01 IMPLANTABLE PULSE GENERATOR |