FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3910005
·
Received July 2, 2014
Report
- Report Number
- 2124215-2014-09838
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 4, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 PACEMAKER AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE BEING OVERSENSED WHICH LED TO PACING INHIBITION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT ASYSTOLE WAS GREATER THAN 2 SECONDS AND OVERSENSING WAS DUE TO UNKNOWN LOCATION OF INSULATION BREACH. THE LEAD WAS CAPPED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388534 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L| R | S603| 4459| 4470 |