FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2812486
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16447
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- September 26, 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
- TX, 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 IMMEDIATELY AFTER THE IMPLANT THE LEADS WERE CHECKED. THE VENTRICULAR LEAD IMPEDANCE AND THRESHOLD MEASUREMENTS WERE HIGH AND VARIABLE. FLUOROSCOPY REVEALED THE LEAD APPEARED TO BE IN THE SAME POSITION. THE LEAD WAS REPOSITIONED DUE TO THE POSSIBILITY OF MICRODISLODGEMENT AND 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 | 79 YR | Required Intervention | 5086MRI IMPLANTABLE PACING LEAD| RVDR01 IMPLANTABLE PULSE GENERATOR |