FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1945697
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20176
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 12, 2010
- Report Date
- October 12, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AN ATTEMPT HAS BEEN MADE TO HAVE THESE PRODUCTS RETURNED TO BOSTON SCIENTIFIC. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT DEVELOPED A POCKET INFECTION. THE DEVICE, A TRANSVENOUS RIGHT ATRIAL (RA) LEAD, AND A TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THESE OBSERVATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Life Threatening| R | 0158| 0184| 0185| E110| 4086 |