FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 3905411
·
Received July 1, 2014
Report
- Report Number
- 2124215-2014-12248
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Date of Event
- May 9, 2014
- Report Date
- May 9, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
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 LEAD WAS ATTEMPTED AT IMPLANT DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN WAS DISSATISFIED WITH THE THRESHOLD MEASUREMENTS OBTAINED WITH THIS LEAD. A DIFFERENT MODEL LEAD WAS USED WITH ACCEPTABLE THRESHOLD MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 382383 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | 4469| K063| 4136| 4137 |