MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-12-10 for BIOMONITOR 2-AF 398493 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[170129485]
This device was explanted due to patient complaints of discomfort. There is currently no indication that a new device has been implanted. Should additional information become available, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5
[182472915]
Discomfort was observed following the implantation of this biotronik device. Therefore the device as received was visually inspected. The visual inspection revealed no external anomalies. 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. In conclusion there was no indication of a material or manufacturing problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2019-05510 |
| MDR Report Key | 9446764 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-12-10 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-09-28 |
| Date Added to Maude | 2019-12-10 |
| 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 | 2019-12-10 |
| Returned To Mfg | 2019-12-10 |
| Model Number | 398493 |
| Catalog Number | SEE MODEL NO. |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN 12359 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-12-10 |