FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1950984
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-22915
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 19, 2010
- Report Date
- November 19, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD WAS SEEN IN CLINIC DUE TO RECEIVING A SHOCK. THE SHOCK WAS DELIVERED FOR NEW ONSET OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE DEVICE WAS REPROGRAMMED. IT WAS ALSO NOTED THAT THE PATIENT HAD A VERY SMALL PERICARDIAL EFFUSION FROM THIS LEAD. NO INTERVENTION WAS NECESSITATED DUE TO THE PERICARDIAL EFFUSION. 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 | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | E110| 4135| 0184 |