MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-07 for 1.27MM 1028146 manufactured by Medtronic.
[4418971]
Add'l info received from report on 04/15/2014: yes, you may give the contact info to the rep. I also will have the doctor who presented the problem to us on these sheehy tubes be available to them as well. She will also be giving me the names of 3 add'l pts who had early extrusion with these tubes later today. One had this happen twice. I will do further research on the new pts and try to narrow down the lots/product number used during that time period on our purchase orders from the company as these tubes are not required to have lot numbers etc.. Documented in pt record. Per operating room staff, they did save a couple of the tubes that were replaced due to early extrusion for the medtronic rep to pick up.
Patient Sequence No: 1, Text Type: D, B5
[16449369]
Physician complaint of early extrusion of sheehy 1. 27 mm ear ventilation tube on several pts (8). These early extrusions occurred as early as a few months after placement (per physician they should stay in 12-18 months). Date placement of initial tubes ranged from (b)(6) 2012 through (b)(6) 2013. These early extrusions required another surgical procedure to replace them for 7 pts so far. Physician can previously recall only one pt in her practice of several years who experienced that prior to these most recent 8 pts. Physician has stopped using these particular tubes until problem is identified, i. E different mfg process, different site of mfr (i. E foreign country) etc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034351 |
| MDR Report Key | 3624408 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-02-06 |
| Date Added to Maude | 2014-02-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Catalog Number | 1028146 |
| Lot Number | 0205263090 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0205408106 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0205608969 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0205809485 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0205993180 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0206082841 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0206198619 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 7 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0206776274 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 8 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0206933852 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 9 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0207425339 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 10 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Brand Name | 1.27MM |
| Generic Name | EAR VENTILATION TUBES |
| Product Code | ETD |
| Date Received | 2014-02-07 |
| Lot Number | 0207425339 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 11 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-07 |