FDA Adverse Event
Injury
Summary report: N
SELUTE PICOTIP
MDR report key: 1043114
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33531
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 15, 2008
- Report Date
- February 15, 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 | SELUTE PICOTIP | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4034 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | THE DEVICE 1290/807406 WAS IMPLANTED 15-FEB-2008| THE DEVICE 1290/808110 WAS IMPLANTED 14-FEB-2008| THE DEVICE 4053/417896 WAS IMPLANTED 14-FEB-2008 |