FDA Adverse Event
Injury
Summary report: N
INTERVENE
MDR report key: 1944649
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-20009
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 7, 2010
- Report Date
- October 7, 2010
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NVY
- PMA / PMN Number
- P940008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THERE WERE NO ADVERSE EVENTS REPORTED FOLLOWING THIS INVASIVE PROCEDURE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A SCHEDULED DEVICE REPLACEMENT DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). WHEN THE POCKET SITE WAS OPENED, THE PHYSICIAN FOUND THAT THE POCKET WAS INFECTED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WILL BE SCHEDULED A SYSTEM EXTRACTION IN THE NEAR FUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERVENE | IMPLANTABLE LEAD | NVY | GUIDANT ANGLETON/ST. PAUL | 497-23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| L | H177| 4549| 497-23| 432-04| 101-09| 1861 |