FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2811743
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16874
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 RIGHT VENTRICULAR LEAD IMPEDANCE HAD RISEN FROM 830 OHMS AT IMPLANT TO 1632 OHMS. THE LEAD WAS CAPPED AND REPLACED. IT WAS FURTHER REPORTED THAT AT THE LEAD REVISION, THE DEVICE WAS PROGRAMMED TO THE DOO MODE BUT WHEN THE NEW LEAD WAS INSERTED, NO PACING WAS NOTED. THE DEVICE SWITCHED TO UNIPOLAR PACING EVEN UNDER THE DOO MODE. THE DEVICE WAS REPROGRAMMED BIPOLAR DOO, THE NEW LEAD WAS REINSERTED BUT THERE WAS STILL NO PACING. THE DEVICE WAS EXPLANTED AND REPLACED. 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 | 76 YR | Hospitalization| R | 4076 IMPLANTABLE PACING LEAD |