FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2151724
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06054
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 1, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- 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 PATIENT DEVELOPED AN INFECTION. THE PREVIOUSLY ABANDONED RIGHT VENTRICULAR LEAD WAS REMOVED FROM THE RIGHT SIDE OF THE PATIENT'S BODY. THE SYSTEM IMPLANTED ON THE LEFT SIDE OF THE PATIENT'S BODY WAS LEFT IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | 1194| 4087| 1180| S602| 4034| 4086 |