FDA Adverse Event
Malfunction
Summary report: N
ACUITY STEERABLE
MDR report key: 1042316
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34327
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 7, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY STEERABLE | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4555 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other | THE DEVICE 4087/272520 WAS IMPLANTED 27-MAR-2007| THE DEVICE H170/367031 WAS IMPLANTED 07-MAR-2008| THE DEVICE 4543/135536 WAS IMPLANTED 07-MAR-2008| THE DEVICE 4088/227280 WAS IMPLANTED 27-MAR-2007| THE DEVICE 1298/230396 WAS IMPLANTED 27-MAR-2007| THE DEVICE 0185/191765 WAS IMPLANTED 07-MAR-2008 |