MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-05 for BONEBRIDGE BCI BONE CONDUCTION IMPLANT manufactured by Med-el Elektromedizinische Geraete Gmbh.
[135163892]
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
[135163893]
In (b)(6) 2018 the user started to experience intermittencies with the device. Initially, the intermittencies only occurred when yawning and then progressed to intermittencies also when chewing. Currently the intermittencies also occur when the user is talking and happens, so often that use of the audio processor was stopped. There were no accidents or trauma reported. No mri scan was conducted either. The user has good benefit with the device when it is functioning. Re-implantation will be considered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2019-00101 |
| MDR Report Key | 8303969 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-05 |
| Date of Report | 2019-04-26 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-02-05 |
| 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 | 3 |
| Brand Name | BONEBRIDGE |
| Generic Name | BCI BONE CONDUCTION IMPLANT |
| Product Code | PFO |
| Date Received | 2019-02-05 |
| Returned To Mfg | 2019-04-01 |
| Model Number | BCI BONE CONDUCTION IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-05 |