FDA Adverse Event
Injury
Summary report: N
BIOPORE
MDR report key: 2051674
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03338
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- December 22, 2010
- Report Date
- February 21, 2011
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NVN
- PMA / PMN Number
- K883602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS RA LEAD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS BECAUSE IT WAS CAPPED AND ABANDONED. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS ABANDONED SURGICALLY DUE TO INFECTION. IT WAS ALSO NOTED THE ASSOCIATED DEVICE WAS EXPLANTED DUE TO INFECTION. THE ASSOCIATED DEVICE IS A COMPETITOR'S PRODUCT. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPORE | IMPLANTABLE LEAD | NVN | GUIDANT ANGLETON/ST. PAUL | 433-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | (B)(4)| (B)(4)| (B)(4)| 7108 |