FDA Adverse Event
Injury
Summary report: N
DEXTRUS
MDR report key: 1944669
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-20321
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 6, 2010
- Report Date
- October 6, 2010
- Manufacturer
- EXTERNAL MANUFACTURER
- Product Code
- NVN
- PMA / PMN Number
- P950037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY. THE SYSTEM WAS EXPLANTED SECONDARY DUE TO PATIENT INFECTION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION. A NEW DEVICE SYSTEM MAY BE IMPLANTED ONCE THE PATIENT IS CLEARED BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXTRUS | IMPLANTABLE LEAD | NVN | EXTERNAL MANUFACTURER | 4135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | E110| 4135| 0184 |