MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-31 for BIOMONITOR III 436066 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[177203222]
Patient reported that the device began poking out of the implant site when she was lying face-down on a massage table. Patient also reported blood pooling on the underside of her breast. Device was removed, and there is currently no indication that it has been replaced. Should additional information become available, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-00480 |
| MDR Report Key | 9654571 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-10-08 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-07-08 |
| Date Added to Maude | 2020-01-31 |
| 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 | 2020-01-31 |
| Model Number | 436066 |
| 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 12359 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-31 |