FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2791069
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14801
- Event Type
- Injury
- Date Received
- October 15, 2012
- Date of Event
- July 27, 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
- KS, US
- Reporter Occupation
- PATIENT
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 PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE VENTRICULAR LEAD. THE PATIENT DESCRIBED IT AS "PAIN IN THE CHEST THAT RUNS DOWN TO MY DIAPHRAGM AND UP INTO MY SHOULDER". COMPUTED TOMOGRAPHY SCAN WAS DONE AND THE LEAD WAS NOTED TO BE IN THE DIAPHRAGMATIC SPACE. THE LEAD WAS REPOSITIONED 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |