FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2790080
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14699
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 THE ATRIAL LEAD HAD LOW IMPEDANCE MEASUREMENTS AND A LEAD WARNING WAS TRIGGERED. IT WAS ALSO REPORTED THAT THE UNIPOLAR IMPEDANCE WAS MEASURING HIGHER THAN THE BIPOLAR IMPEDANCE. THE ATRIAL LEAD IS BEING MONITORED 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. | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other | 5076 IMPLANTABLE PACING LEAD| SEDR01 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |