FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2203575
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-12357
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- May 31, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 A DAY POST IMPLANT THE PATIENT COMPLAINED OF PAIN WHEN BREATHING. A CT SCAN REVEALED THAT THE LEAD TIP WAS THROUGH THE MYOCARDIUM ABUTTING THE PERICARDIUM. THE LEAD WAS REVISED AND REMAINS IN USE. NO FURTHER 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| L| R | (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |