D
Patient 1
THIS SYSTEM WAS REMOVED DUE TO (B)(6) ENDOCARDITIS ON (B)(6) 2012. THERE IS NO INDICATION THE SYSTEM WAS REPLACED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
MAUDE MDR 2980991
- MDR report key
- 2980991
- Report number
- 1028232-2013-00448
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-09-24
- Date received
- 2013-02-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
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 | SETROX S 45 | PACER LEAD | BIOTRONIK SE & CO. KG | JXK | 350973 | SEE MODEL NO. | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-02-19 | 0 | 1. H |
Event Narratives#
N
Patient 1
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.