FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND IS-1 BI POSITIVE FIX 45CM
MDR report key: 1041638
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-35006
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 4, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND IS-1 BI POSITIVE FIX 45CM | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4086 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other | THE DEVICE 1291/151302 WAS IMPLANTED 22-APR-2008| THE DEVICE 1298/172742 WAS IMPLANTED 05-MAR-2004| THE DEVICE 4087/205253 WAS IMPLANTED 05-MAR-2004| THE DEVICE 4136/282815 WAS IMPLANTED 22-APR-2008 |