MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-04-16 for PROSTHESIS - POLYCEL 1156376 manufactured by Medtronic Xomed Inc..
[5723921]
On (b)(6) 2013 the patient received an auditory ossicle implant for cholesteatoma otitis media of the right ear. It was reported that there were no abnormalities found with the package of the product prior to use. The procedure was completed without incident and the patient's hearing in the right ear was normal in the days following. Recently the patient experienced a complete loss of hearing in the right ear. Given that the patient has congenital deafness in the left ear, the patient now presents with a complete loss of hearing. The physician suggests that the hearing loss in the right ear was caused by other factors such as neuropathy beside the ossicle, a progressive neurological disease, and the fact that cholesteatoma otitis media can lead to hearing loss. The physician does not believe the hearing loss is a result of the medtronic device. A cochlear implant may be implanted at a later date.
Patient Sequence No: 1, Text Type: D, B5
[13190724]
(b)(4). The device remains implanted in the patient. Therefore, a product analysis cannot be performed. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00122 |
| MDR Report Key | 4700131 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-03-22 |
| Date Mfgr Received | 2015-03-22 |
| Device Manufacturer Date | 2012-07-30 |
| Date Added to Maude | 2015-04-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTHESIS - POLYCEL |
| Generic Name | POROUS POLYETHYLENE OSSICULAR REPLACEMENT |
| Product Code | LBM |
| Date Received | 2015-04-16 |
| Model Number | 1156376 |
| Catalog Number | 1156376 |
| Lot Number | 0206054172 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-04-16 |