FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3213705
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-07616
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 15, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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 WAS EXPLANTED DUE TO DISLODGEMENT SECONDARY TO THE PATIENT¿S PHYSICAL POSTURE ISSUES WITH MENTALLY CHALLENGED CONDITION. THERE WAS NO PLAN OF REPLACING OR RE-IMPLANTING RA LEAD SINCE THE PHYSICIAN BELIEVED THE PATIENT WAS NOT PACEMAKER DEPENDENT AND DID NOT EXHIBIT CLINICAL SYMPTOMS. THIS EXPLANTED LEAD WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314450 | FINELINE II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization| L| R | 5076| K173| 4469 |