MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-09-26 for DEVICE 1010020601 MENIETT GENERATOR manufactured by Medtronic Xomed, Inc..
[3922436]
On (b)(6) 2013, the customer reported that the previous day ((b)(6)), the meniett made and extremely loud and painful pop in her ear. The rest of the day it was not working right. It kept showing that it was not level even when it was. Then after a few seconds, it would shut off. She fell two times on (b)(6). When she fell, she hit her head on the fireplace, which caused a knot that she iced down.
Patient Sequence No: 1, Text Type: D, B5
[11189833]
This device is used for therapeutic purposes. Patient is in her (b)(6). (b)(4). Service and repair examined unit and confirmed customer's complaint. We replaced pump due to leak also replaced dead battery and put new feet on the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00524 |
| MDR Report Key | 3371778 |
| Report Source | 00 |
| Date Received | 2013-09-26 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-08-26 |
| Date Mfgr Received | 2013-08-27 |
| Device Manufacturer Date | 2013-04-04 |
| Date Added to Maude | 2014-01-03 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| 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 | DEVICE 1010020601 MENIETT GENERATOR |
| Generic Name | TESTER, AUDITORY IMPEDANCE |
| Product Code | ETY |
| Date Received | 2013-09-26 |
| Returned To Mfg | 2013-09-04 |
| Model Number | 1010020601 |
| Catalog Number | 1010020601 |
| Lot Number | 206892364 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-26 |