D
Patient 1
PER CLEAR STUDY ADVERSE EVENT FORM, THIS PATIENT TESTED POSITIVE FOR STAPH AUREUS IN 2008. THIS SYSTEM WAS REMOVED THE FOLLOWING MONTH. POLYROX 60 BP, MDR 1028232-2009-00915.
MAUDE MDR 1410436
- MDR report key
- 1410436
- Report number
- 1028232-2009-00914
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-03-04
- Date received
- 2009-07-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 6024 JEAN ROAD LAKE OSWEGO OR 97035 US
- Phone
- 877-877-8772
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CYLOS VR | PACEMAKER | BIOTRONIK GMBH AND CO. | DXY | 349811 | 349811 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-07-02 | 0 | 1. H |
Event Narratives#
N
Patient 1
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.