MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-02-15 for LESINSKI FLEX HA PARTIAL OSSICULAR PROSTHESIS 0531 manufactured by Medtronic Xomed.
[780286]
The rn reported that she did a case with the dr on a little girl that had an ear prosthesis put in last year. In a surgery in 2008, dr found the prosthesis that she had put in was broken in 2 pieces. They put in a different prosthesis from the broken one and saved the old prosthesis. The rn can't tell exactly if the pt needed the second surgery (2008), because the prosthesis was broken and not functioning, or if it was for a follow-up/2nd stage repair procedure. This had not been clarified with the dr. The nurse's understanding from the surgeon is that when the prosthesis became exposed, she found it broken in two. She did not use the same prosthesis to replace the one first implanted.
Patient Sequence No: 1, Text Type: D, B5
[7929702]
The prosthesis has not yet been returned, therefore, an evaluation is not possible. Despite several attempts, we have not been able to confirm with the dr that the pt had lost hearing prior to the second surgery, which would confirm that the prosthesis was broken before the surgery. We are submitting this report as a serious injury based on the assumption that the pt's hearing had been lost/impaired. This is the first report of this type on this product, and it is considered to be an isolated occurrence. This report should not be construed as an admission by medtronic xomed dangerous in any respect or that any casual relationship exists between the product and any actual or potential injury. In addition, the submission of a report by medtronic xomed should not be construed as an admission that a reportable event has, in fact, occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2008-00003 |
| MDR Report Key | 998852 |
| Report Source | 07 |
| Date Received | 2008-02-15 |
| Date of Report | 2008-02-15 |
| Date of Event | 2008-01-15 |
| Date Mfgr Received | 2008-01-18 |
| Device Manufacturer Date | 2005-01-28 |
| Date Added to Maude | 2008-02-21 |
| 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 | MIKE MOSBY, SUP |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED ENT |
| Manufacturer Street | 6743 SOUTHPOINT DR. 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 | LESINSKI FLEX HA PARTIAL OSSICULAR PROSTHESIS |
| Generic Name | MIDDLE EAR PROSTHESIS |
| Product Code | ETB |
| Date Received | 2008-02-15 |
| Model Number | 0531 |
| Catalog Number | 0531 |
| Lot Number | NA |
| Device Expiration Date | 2013-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 968639 |
| Manufacturer | MEDTRONIC XOMED |
| Manufacturer Address | JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-15 |