FDA Adverse Event
Injury
Summary report: N
CAPSURE Z NOVUS
MDR report key: 2790653
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-15356
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S38
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WENT TO THE MEDICAL INSTITUTION DUE TO HEARING A PATIENT ALERT. IT WAS FOUND THE PATIENT ALERT WAS DUE TO THE RIGHT ATRIAL (RA) LEAD HAVING IMPEDANCE GREATER THAN 3000 OHMS AND THE LEAD TREND GRAPH SHOWED THERE WAS A GRADUAL IMPEDANCE INCREASE. THE PACING MODE WAS REPROGRAMMED TO INACTIVATE THE RA LEAD WHICH REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE Z NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention | 6943 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4092 IMPLANTABLE PACING LEAD |