FDA Adverse Event
Other
Summary report: N
PHILOS SR
MDR report key: 567868
·
Received January 12, 2005
Report
- Report Number
- 1028232-2004-00155
- Event Type
- Other
- Date Received
- January 12, 2005
- Date of Event
- December 6, 2004
- Report Date
- December 21, 2004
- Manufacturer
- BIOTRONIK, INC.
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
EXPLANTED DEVICE RECEIVED FROM UNKNOWN SOURCE WITH NO REASON FOR REPLACEMENT LISTED ON THE OOS REPORT FORM. ADDITIONALLY, NO CLINICAL INFO WAS PROVIDED.
Description of Event or Problem · 1
EXPLANTED DEVICE RECEIVED FROM UNKNOWN SOURCE WITH NO REASON FOR REPLACEMENT LISTED ON THE OOS REPORT FORM. ADDITIONALLY, NO CLINICAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILOS SR | PACEMAKER | DXY | BIOTRONIK, INC. | 331 446 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization |