CAPSURE SP NOVUS
Report
- Report Number
- 2649622-2012-16044
- Event Type
- Injury
- Date Received
- October 31, 2012
- Report Date
- February 7, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089/S38
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
PRODUCT EVENT SUMMARY - EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PRIMARY ANALYSIS INDICATED THAT THERE WAS OVERSENSING. IT WAS ALSO NOTED THAT RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS OUT OF RANGE (OOR)/LOW.
IT WAS REPORTED THAT THE RIGHT VENTRICLE (RV) LEAD TREND SHOWS LOW IMPEDANCE. NOISE AND OVERSENSING WERE ALSO NOTED WITH INHIBITION OF PACING. THE PATIENT HAS BEEN SCHEDULED FOR A LEAD REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE RIGHT VENTRICLE (RV) LEAD TREND SHOWS LOW IMPEDANCE. NOISE AND OVERSENSING WERE ALSO NOTED WITH INHIBITION OF PACING. THE PATIENT HAS BEEN SCHEDULED FOR A LEAD REPLACEMENT. 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 SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00092 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR| 5592 IMPLANTABLE PACING LEAD |