FDA Adverse Event
Malfunction
Summary report: N
SWEET PICOTIP RX
MDR report key: 1043268
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33377
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 8, 2008
- Report Date
- February 8, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWEET PICOTIP RX | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4054 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other | THE DEVICE 0158/138928 WAS IMPLANTED 21-APR-2004| THE DEVICE 4054/456905 WAS IMPLANTED 08-FEB-2008| THE DEVICE A155/106447 WAS IMPLANTED 21-APR-2004| THE DEVICE T167/113811 WAS IMPLANTED 08-FEB-2008 |