MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2011-04-15 for PROSTHESIS 1156236 FISCH PISTON .6X6.0L manufactured by Medtronic Xomed, Inc..
[20825749]
A medwatch form was not received from the reporter. Any missing or incomplete data on this form 3500a is the result of information not being provided or released by the reporter despite attempts to obtain the required information. The product was being used for treatment, not diagnosis. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20840552]
A medtronic sales rep reported for a doctor in the netherlands that a patient was implanted with an ossicular reconstruction implant on (b)(6) 2010. The doctor states: "teflon (fluoroplastic) shaft of the prostheses was spontaneously separated from the (platinum) wire after successful placement some time ago. Injury of the inner ear. " the prosthesis was removed and replaced with a new prosthesis during a revision surgery on (b)(6) 2011. No further patient complication reported. Product analysis found that the two components of the prosthesis were returned and that the unbroken, fully intact platinum wire component came out of the fluoroplastic piston component. Returned prosthesis demonstrated that it was produced correctly and met the manufacturing specification at the time of manufacture. Conclusion: a review of the manufacturing records showed no anomalies during the manufacture of this product. Returned prosthesis demonstrated that it was produced correctly and met the manufacturing specification at the time of manufacture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2011-00024 |
| MDR Report Key | 2059758 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2011-04-15 |
| Date of Report | 2011-03-21 |
| Date of Event | 2011-03-21 |
| Date Mfgr Received | 2011-03-21 |
| Device Manufacturer Date | 2009-04-13 |
| Date Added to Maude | 2011-04-15 |
| 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 |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| 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 1156236 FISCH PISTON .6X6.0L |
| Product Code | ETB |
| Date Received | 2011-04-15 |
| Returned To Mfg | 2011-04-12 |
| Model Number | 1156236 |
| Catalog Number | 1156236 |
| Lot Number | 61106400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-04-15 |