FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2810615
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15773
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THAT DATA REVEALED NO ANOMALIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS FAR FIELD R-WAVE AND UNDERSENSING ON THE ATRIAL LEAD. THERE WAS ALSO REPORT OF SMALL P-WAVES. THE PATIENT WAS REPORTED TO HAVE HEARD A STEADY TONE INTERMITTENTLY, WHICH WAS DETERMINED TO BE DUE TO MAGNET EXPOSURE. THE LEAD 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 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1056T COMPETITOR IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD |