MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-11-22 for OTOLOGY VENT TUBE XOM UNK OTOLOGY manufactured by Medtronic Xomed Inc..
[92725269]
The device has not been returned for evaluation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[92725270]
This report addresses patient 1 of 2 that had persistent tympanic perforation. The article referenced below evaluates the intra- and postoperative effects of untreated otitis media with effusion (ome) in cochlear implant (ci) patients and assesses the role of ventilation tube (vt) introduction before implantation. One hundred ninety-four cases (implanted ears) were included. Ninety-nine aerated, 39 treated with vt, and 56 with untreated ome. Mean age at implantation was 3. 1, 2. 1, and 1. 6 years, respectively. Intraoperative findings were all manageable and were not associated with higher perioperative complication rates. The rates of early and late postoperative complications were low in all groups, with no significant differences between groups. Tympanic membrane perforations were encountered in two patients after vt extrusion. Rate of otorrhea was 20% during the first year after implantation and 5% at last follow up. Reference: meirav sokolov, ohad hilly, david ulanovski, yotan shkedy, joseph attias, and eyal raveh. Is it necessary to treat otitis media with effusion (ome) prior to cochlear implantation? Results over a long-term follow-up. Otol neurotol 37:1529-1534, 2016. (b)(4). Patient 2 of 2 with persistent tympanic perforation. Will be reported via (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2017-00425 |
| MDR Report Key | 7052119 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2009-01-01 |
| Date Mfgr Received | 2017-10-25 |
| Date Added to Maude | 2017-11-22 |
| 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 | ANGIE DEMO |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| 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 | OTOLOGY VENT TUBE |
| Product Code | ETD |
| Date Received | 2017-11-22 |
| Model Number | XOM UNK OTOLOGY |
| Catalog Number | XOM UNK OTOLOGY |
| 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. Other | 2017-11-22 |