FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2131254
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10451
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 25, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 DURING IMPLANT, THE LEAD HAD HIGH IMPEDANCE AND SENSING DIFFICULTIES WHEN VIEWING VALUES THROUGH THE ANALYZER. IT WAS ADVISED TO CHECK THE LEAD THROUGH THE DEVICE SINCE THAT IS THE TRUE IMPEDANCE. THE LEAD WAS IMPLANTED 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | (B)(4) IMPLANTABLE PULSE GENERATOR |