FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2812697
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-17186
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 12, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 THERE WAS NO SENSING OF P WAVES ON THE ATRIAL LEAD IN UNIPOLAR OR BIPOLAR AFTER A CORONARY ARTERY BYPASS SURGERY. DIFFERENT SENSITIVITY SETTINGS WERE ATTEMPTED. THE CALLER DID NOT BELIEVE THE PROCEDURE WAS NEAR THE ATRIAL LEAD BUT NOTED THAT THE PATIENT WAS ON LITHIUM WHICH CAN CAUSE SENSING ISSUES. FOLLOWUP INFORMATION FROM THE CLINIC INDICATED THAT NO REPROGRAMMING OR INTERVENTION WAS DONE AND THAT THE LEAD IS FINE 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 | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | (B)(4) IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD |