FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1851832
·
Received October 4, 2010
Report
- Report Number
- 2124215-2010-14432
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- June 11, 2010
- Report Date
- July 7, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENT WITH DYSPNEA DURING EXERCISE. WHEN PRESENTED TO THE HOSPITAL POOR STIMULATION WAS NOTED AND A POSSIBLE DISLODGEMENT OF THE RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED WHEN PERFORMING AN X-RAY. AT THIS TIME THE RV LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | 4096| F110| 0186 |