MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-19 for SETROX S 45 350973 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[3129620]
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.
Patient Sequence No: 1, Text Type: D, B5
[10636757]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2013-00448 |
| MDR Report Key | 2980991 |
| Report Source | 05,07 |
| Date Received | 2013-02-19 |
| Date of Report | 2013-02-05 |
| Date of Event | 2012-09-24 |
| Date Mfgr Received | 2013-03-21 |
| Device Manufacturer Date | 2011-07-08 |
| Date Added to Maude | 2013-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Manufacturer G1 | BIOTRONIK SE & CO KG |
| Manufacturer City | BERLIN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SETROX S 45 |
| Generic Name | PACER LEAD |
| Product Code | JXK |
| Date Received | 2013-02-19 |
| Model Number | 350973 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN D-12359 GM D-12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-02-19 |