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 2014-11-24 for PROSTHESIS 1156603 PLAT/TI .5MMX4.5MM manufactured by Medtronic Xomed, Inc.
[5295416]
It was reported that the patient suffered what appeared to be? Loose wire? Syndrome, where the patient experiences "blown speaker" distortion, because the crimp on the prosthesis became loose following surgery. On this particular patient, he re-crimped the patient? S prosthesis, but it did not correct the problem. The doctor completed? A first revision and the incus and positioning of the pros theses appeared normal,? But the as this did not correct the issue, the patient will return for a second revision and replacement of the product.
Patient Sequence No: 1, Text Type: D, B5
[12500233]
(b)(4). The product analysis has not been completed at this time. Method: no testing methods performed. Results: results pending completion of evaluation.
Patient Sequence No: 1, Text Type: N, H10
[27185315]
The product analysis found that there was evidence of biological contaminants (based off of the reactivity with hydrogen peroxide). There were no non-conformities which would have resulted in the reported malfunction when examined by (b)(6) (surgeon). Additionally, the incoming qa records indicate that every lot of platinum wire dating back to (b)(6) 2012 have passed all inspections and there have been no recent changes to the manufacturing process. Method: actual device evaluated. (b)(4). Method: visual inspection; method: labeling. Results: no failure detected. (b)(4). Conclusion: no failure detected, device operated within specification. (b)(4). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101038589]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00302 |
| MDR Report Key | 4274158 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2014-11-24 |
| Date of Report | 2014-10-30 |
| Date Mfgr Received | 2014-12-15 |
| Date Added to Maude | 2014-11-24 |
| 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 | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| 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 1156603 PLAT/TI .5MMX4.5MM |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2014-11-24 |
| Returned To Mfg | 2014-11-20 |
| Model Number | 1156603 |
| Catalog Number | 1156603 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-24 |