FDA Adverse Event
Injury
Summary report: N
2124215-2011-08512
MDR report key: 2163135
·
Received July 15, 2011
Report
- Report Number
- 2124215-2011-08512
- Event Type
- Injury
- Date Received
- July 15, 2011
- Date of Event
- April 21, 2011
- Report Date
- April 21, 2011
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NVN | GUIDANT PUERTO RICO BV | BRADY LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Hospitalization| L| R | S601| (B)(4)| 4269| 1184 |