FDA Adverse Event
Death
Summary report: N
FINELINE II
MDR report key: 637752
·
Received February 9, 2004
Report
- Report Number
- 2124215-2004-06318
- Event Type
- Death
- Date Received
- February 9, 2004
- Date of Event
- October 1, 2003
- Report Date
- October 1, 2003
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN EXPERIENCE DIFFICULTY, AND USED FORCE, WHILE TRYING TO ADVANCE THE 4087 (200955) IMPLANTABLE LEAD THROUGH THE INTRODUCER. THE LEAD WAS EXPLANTED AND RETURNED FOR ANALYSIS. AFTER POCKET CLOSURE, THE PATIENT'S HEART STOPPED BEATING. AN ELECTROCARDIOGRAM (EKG) CONFIRMED PACING SPIKES, HOWEVER ATRIAL AND VENTRICULAR IMPLANTABLE LEAD CAPTURE WAS NOT DEMONSTRATED IN AAT, VVI OR VDD MODES AT MAXIMUM OUTPUTS. THE PATIENT WITH THIS PACING SYSTEM EXPIRED DURING THE IMPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4456 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Death |