MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-23 for BIOMONITOR 2-AF 398493 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[176256103]
An infection was observed following the implantation of this biotronik device. The sterilization process was investigated. The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc. , are within its specified ranges for each distributed device. Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process. Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident. In summary, the infection was not device related.
Patient Sequence No: 1, Text Type: N, H10
[176256104]
The patient was diagnosed with inflammation and infection at the implant site. No actions were taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-00390 |
| MDR Report Key | 9623983 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-09-27 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-02-07 |
| Date Added to Maude | 2020-01-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMONITOR 2-AF |
| Generic Name | IMPLANTABLE CARDIAC MONITOR |
| Product Code | MXD |
| Date Received | 2020-01-23 |
| Model Number | 398493 |
| Catalog Number | SEE MODEL NO. |
| Device Expiration Date | 2020-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN 12359 DE 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-23 |