FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 3971333
·
Received July 31, 2014
Report
- Report Number
- 2124215-2014-14194
- Event Type
- Injury
- Date Received
- July 31, 2014
- Date of Event
- June 29, 2014
- Report Date
- July 28, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DEFORMED CONDUCTOR COILS WERE NOTED. THE LEAD TIP AND TINES HAD NO SIGNS OF DAMAGE WHICH WOULD LEAD TO DISLODGEMENT. THE DEFORMED COILS MAY OR MAY NOT HAVE BEEN RELATED TO PATIENT'S TWIDDLER'S SYNDROME.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED AS IT HAD DISLODGED DUE TO TWIDDLER¿S SYNDROME. A NEW RA LEAD WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446951 | FINELINE II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R | 4472| 0184| E143| 4543 |