MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-04 for VIBRANT SOUNDBRIDGE VORP manufactured by Med-el Elektromedizinische Geraete Gmbh.
[181977697]
Device investigation shows a multiple damaged device and due to the limited information from the field, is not clear if the device was functional whilst it was implanted. However, according to the patient report and the device explant report form the device was explanted due to insufficient hearing ability with the device, most likely due to the medical condition of the middle ear which leads to otorrhoea. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
[181977698]
The explant was received from the clinic staff. It was reported that the device was explanted due to insufficient hearing ability with the device. According to the information on the device explant report form the symptom leading to explantation was otorrhoea. The user was re-implanted with a bone conduction implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2020-00139 |
| MDR Report Key | 9784334 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-04 |
| 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 | VIBRANT SOUNDBRIDGE |
| Generic Name | MIDDLE EAR IMPLANT |
| Product Code | MPV |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-01-21 |
| Model Number | VORP |
| 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 | 2020-03-04 |