FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND IS-1 BI POSITIVE FIX 45CM
MDR report key: 1254059
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40647
- Event Type
- Malfunction
- Date Received
- November 11, 2008
- Date of Event
- September 17, 2008
- Report Date
- September 24, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
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 | 77 YR | Other | THE DEVICE 0184/102865 WAS IMPLANTED 23-JUN-2004| THE DEVICE 6481 026526 WAS USED DURING THE EVENT.| THE DEVICE E110/004851 WAS IMPLANTED 24-SEP-2008| THE DEVICE T125/108186 WAS IMPLANTED 23-JUN-2004 |