FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3210998
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-07754
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 29, 2013
- Report Date
- April 29, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
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 RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE FRACTURED DUE TO CLAVICULAR CRUSH. OVERSENSING AND PACING INHIBITION WERE ALSO OBSERVED DUE DAMAGE TO BOTH LEADS. BOTH LEADS WERE SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEADS WERE NOT AVAILABLE FOR RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311195 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| L| R | A155| 4470| 0158| E140| 0292 |