MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-07 for BONEBRIDGE BCI601 BONE CONDUCTION IMPLANT manufactured by Med-el Elektromedizinische Geraete Gmbh.
[153675383]
The device has not been explanted. If it should be explanted, it is to be returned to the manufacturer for evaluation. When available, a device failure analysis will be submitted as a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[153675384]
The user has no longer auditory sensation with the device unless pressing the audio processor firmly onto the implant. The external parts were checked and no problems were reported. The magnet strength for the audio processor is 4, and a 7 (5+2) strength magnet was also tried but the issues remained. There is no problem with the adhesion of the audio processor to the implant. The device is currently not in use and the recipient is currently wearing a bone conduction hearing aid. Re-implantation has been suggested by vibrant clinical support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2019-00600 |
| MDR Report Key | 8868900 |
| Date Received | 2019-08-07 |
| Date of Report | 2019-08-07 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-08-06 |
| Date Added to Maude | 2019-08-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA SIMONOTTI |
| Manufacturer Street | FUERSTENWEG 77A |
| Manufacturer City | INNSBRUCK 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal | 6020 |
| Manufacturer Phone | 57788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONEBRIDGE |
| Generic Name | BCI BONE CONDUCTION IMPLANT |
| Product Code | MPV |
| Date Received | 2019-08-07 |
| Model Number | BCI601 BONE CONDUCTION IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
| Manufacturer Address | INNSBRUCK AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-07 |