FDA Adverse Event
Other
Summary report: N
ACTROS DR
MDR report key: 637287
·
Received September 19, 2005
Report
- Report Number
- 1028232-2005-00115
- Event Type
- Other
- Date Received
- September 19, 2005
- Date of Event
- August 12, 2005
- Report Date
- September 7, 2005
- Manufacturer
- BIOTRONIK GMBH AND CO.,
- Product Code
- DTB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
DEVICE RETURNED WITH NO OOS FORM FROM MEDICAL CENTER. LISTED ONLY AS EXPLANT. DEVICE WENT TO ERI ON 7/05 BY INTERROGATION.
Description of Event or Problem · 1
DEVICE RETURNED WITH NO OOS FORM FROM MONROE REGIONAL MEDICAL CENTER. LISTED ONLY AS EXPLANT. DEVICE WENT TO ERI ON 07/25/2005 BY INTERROGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTROS DR | PACEMAKER | DTB | BIOTRONIK GMBH AND CO., | 120084 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |