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 2020-02-17 for BIOMONITOR III 436066 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[179626693]
The device is currently not available for analysis. No conclusion can be drawn at this time. No additional information is available at the moment. The file is closed. The investigation will be re-opened should additional data become available.
Patient Sequence No: 1, Text Type: N, H10
[179626854]
Due to motion dependent (movements of patient) dislocation of the device, the patient had severe pain at the place where the biomonitor iii was inserted. The patient was hospitalized. Biomonitor iii was explanted and another loop recorder was implanted (the positon of the new device was changed).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-00769 |
| MDR Report Key | 9716694 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-17 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-02-17 |
| 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 III |
| Generic Name | IMPLANTABLE CARDIAC MONITOR |
| Product Code | MXD |
| Date Received | 2020-02-17 |
| Model Number | 436066 |
| Catalog Number | SEE MODEL NO. |
| 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 | 2020-02-17 |