FDA Adverse Event
Injury
Summary report: N
TRANSVENOUS
MDR report key: 1945778
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20743
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 12, 2010
- Report Date
- October 12, 2010
- Manufacturer
- HISTORICAL PUERTO RICO
- Product Code
- NVN
- PMA / PMN Number
- K893957
- Adverse Event
- 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 | TRANSVENOUS | IMPLANTABLE LEAD | NVN | HISTORICAL PUERTO RICO | 4271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Life Threatening| R | 1273| 4087| 4271| 4088| (B)(4)| 4285| S601| 1298 |