MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-06 for BONEBRIDGE BCI601 BONE CONDUCTION IMPLANT 52180 manufactured by Med-el Elektromedizinische Geraete Gmbh.
[183543729]
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
[183543730]
The audiologist reported that the initial activation went fine but some part of the implant is sticking out and poking up the skin. The user also reports a sound like 'pebbles in a tin can' rattling which the audiologist still has not been able to resolve, this noise was first reported on (b)(6) 2020. The audiologist feels the implant may not been fixed well. The surgeon has ordered a ct scan and the audiologist is awaiting his feedback.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2020-00087 |
| MDR Report Key | 9676170 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Model Number | BCI601 BONE CONDUCTION IMPLANT |
| Catalog Number | 52180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-02-06 |