FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1950516
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22713
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Date of Event
- November 19, 2010
- Report Date
- November 17, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD REVEALED INCREASING PACING IMPEDANCES SINCE (B)(6), 2010. AT IMPLANT, THE PACING IMPEDANCES WERE 800 OHMS AND AT THE FOLLOW UP VISIT ON (B)(6), 2010 THE PACING IMPEDANCES WERE 2,869 OHMS. THERE WAS NO DECREASE IN SENSING AND THE SHOCK IMPEDANCE WAS STABLE. THE LEAD REMAINS IMPLANTED WITH NO PROGRAMMING CHANGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |