MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-24 for BONEBRIDGE BCI601 BONE CONDUCTION IMPLANT manufactured by Med-el Elektromedizinische Geraete Gmbh.
[184630519]
Device investigation points to a malfunction of the device. The root cause for the device failure is a non-hermetic transducer, which led to loosening of the internal part of the transducer housing. The problems described in the patient report appear to match the damage found. This is a combined initial and final report.
Patient Sequence No: 1, Text Type: N, H10
[184630520]
The user was unable to use the device as loud sounds (e. G. Raised voice or tv) distort and cause high discomfort. The device appeared to function normally at conversational level. Discomfort was described as "vibration of own voice" if lying on the implanted side without wearing any external devices. There is no discomfort if lying on the contralateral side. The device has been explanted. The user was not re-implanted in order to monitor the medical condition reported by the user. Re-implantation is planned for (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2020-00190 |
| MDR Report Key | 9870848 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-03-24 |
| 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 | MPV |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-02-07 |
| Model Number | BCI601 BONE CONDUCTION IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2020-03-24 |