MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2015-03-05 for PROSTHESIS ENDOLYMPHATIC - POLYCEL 1156404 manufactured by Medtronic Xomed Inc..
[5556048]
It was reported that during insertion, while in the patient, the two pieces of the device came apart and the customer was unable to place them back together. The fragment(s) were successfully retrieved. A replacement device was used to complete the case.
Patient Sequence No: 1, Text Type: D, B5
[13023041]
(b)(4). The device was discarded by the customer. Therefore, an analysis cannot be performed. Method: no testing methods performed. (b)(4). This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[101901295]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00065 |
| MDR Report Key | 4573644 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-03-05 |
| Date of Report | 2015-02-09 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-02-09 |
| Date Added to Maude | 2015-04-06 |
| 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 | 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 ENDOLYMPHATIC - POLYCEL |
| Generic Name | TUBE, SHUNT, ENDOLYMPHATIC |
| Product Code | ESZ |
| Date Received | 2015-03-05 |
| Model Number | 1156404 |
| Catalog Number | 1156404 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-03-05 |