FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 750765
·
Received August 9, 2006
Report
- Report Number
- 2124215-2006-15036
- Event Type
- Malfunction
- Date Received
- August 9, 2006
- Date of Event
- April 24, 2006
- Report Date
- April 24, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED, DUE TO HIGH THRESHOLDS AND IMPEDANCE MEASUREMENTS. DURING THE PROCEDURE, THE ATRIAL LEAD (4470) WAS INADVERTENTLY DAMAGED. THIS LEAD WAS REMOVED AND REPLACED. EXPLANTED DEVICE INFORMATION, 1298 180588 ELECTIVE REPLACEMENT, 4471 310815 OTHER, 4470 423041 OTHER, 4471 HIGH THRESHOLD, HIGH IMPEDANCE. NO ADVERSE EVENTS. NEW SYSTEM IMPLANTED ON RIGHT SIDE. 4470 DAMAGED DURING PROCEDURE. LEAD 4086 153681 EXPLANTED 04/24/2006. OUT OF SERVICE DATE 05/06/2004. 4456 349333 REMAINS IMPLANTED AND OOS.,
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4471 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |