FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2161596
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-08169
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD AND CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DISPLAYED A SINGLE EPISODE OF NOISE. THE NOISE WAS OVERSENSED LEADING TO PACING INHIBITION WITH ASYSTOLE. NOISE WAS NOT ABLE TO BE RECREATED. ALL LEAD DIAGNOSTICS WERE NORMAL. THE PHYSICIAN PLANED TO MONITOR THE SYSTEM FOR THE TIME BEING. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | 4524| 4244| H175| 0158 |