FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3210159
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-07397
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 16, 2013
- Report Date
- October 8, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
Additional Manufacturer Narrative · 1
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Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS DISCARDED FOLLOWING EXPLANT AND WILL NOT BE RETURNED. 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 VENTRICULAR (RV) LEAD DISLODGED ONE DAY POST IMPLANT. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
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Description of Event or Problem · 1
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311103 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| L| R | 4469| 4470| K173| 4087 |