MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-12 for VIBRANT SOUNDBRIDGE VORP manufactured by Med-el Elektromedizinische Geraete Gmbh.
[141723175]
(b)(4). The device has been explanted and should 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
[141723176]
The surgeon reported that the user was no longer receiving sound through his device. The device has been explanted. As per new information, the user's hearing performance has improved and no longer meets the candidacy for this device and is now a candidate for conventional amplification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2019-00310 |
| MDR Report Key | 8507860 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-12 |
| Date of Report | 2019-07-15 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-04-12 |
| 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 | 2019-04-12 |
| Returned To Mfg | 2019-05-08 |
| Model Number | VORP |
| 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 | 1. Required No Informationntervention | 2019-04-12 |