FDA Adverse Event
Malfunction
Summary report: N
PROSTHESIS ENDOLYMPHATIC - POLYCEL
MDR report key: 4573644
·
Received March 5, 2015
Report
- Report Number
- 1045254-2015-00065
- Event Type
- Malfunction
- Date Received
- March 5, 2015
- Date of Event
- February 5, 2015
- Report Date
- February 9, 2015
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- ESZ
- PMA / PMN Number
- K834094
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS DISCARDED BY THE CUSTOMER. THEREFORE, AN ANALYSIS CANNOT BE PERFORMED. METHOD: NO TESTING METHODS PERFORMED. (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INSERTION, WHILE IN THE PATIENT, THE TWO PIECES OF THE DEVICE CAME APART AND THE CUSTOMER WAS UNABLE TO PLACE THEM BACK TOGETHER. THE FRAGMENT(S) WERE SUCCESSFULLY RETRIEVED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156154 | PROSTHESIS ENDOLYMPHATIC - POLYCEL | TUBE, SHUNT, ENDOLYMPHATIC | ESZ | MEDTRONIC XOMED INC. | 1156404 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |