FDA Adverse Event
Other
Summary report: N
PHILOS II DR-T
MDR report key: 739189
·
Received July 21, 2006
Report
- Report Number
- 1028232-2006-00142
- Event Type
- Other
- Date Received
- July 21, 2006
- Report Date
- June 9, 2006
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DXY
- PMA / PMN Number
- p950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON 7/13/2006, ACE STUDY SURVEILLANCE FORM RECEIVED FROM CLINICAL. PT WAS HOSPITALIZED DUE TO INFECTION. NO OTHER INFORMATION FROM PHYSICIAN, SYSTEM STILL IMPLANTED AND FOLLOW-UPS RECEIVED FROM CENTER. ON 7/18/2006, CONTACTED PHYSICIANS OFFICE. INFECTION WAS ON THE INCISION AREA, BUT NOT IN THE PACEMAKER POCKET. PATIENT WAS TREATED SUCCESSFULLY WITH IV ANTIBIOTICS AND RELEASED. DEVICE DID NOT NEED TO BE EXPLANTED AND REMAINS IMPLANTED. THIS IS PART OF A SYSTEM THAT INCLUDES: SELOX SR 53, SN: 24134596, MDR# 06-0143. SELOX SR 45, SN: 24136066, MDR# 06-0144. REVIEW OF CLINICAL STUDIES SHOWED THAT THIS DID NOT HAVE AN MDR REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILOS II DR-T | PACEMAKER | DXY | BIOTRONIK GMBH AND CO. | 343 017 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization |