MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PROSTHESIS - POLYCEL; POROUS POLYETHYLENE OSSICULAR REPLACEMENT

Model Number 1156376

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hearing Loss (1882)

Event Type  Injury  

Event Description

On (b)(6) 2013 the patient received an auditory ossicle implant for cholesteatoma otitis media of the right ear.It was reported that there were no abnormalities found with the package of the product prior to use.The procedure was completed without incident and the patient's hearing in the right ear was normal in the days following.Recently the patient experienced a complete loss of hearing in the right ear.Given that the patient has congenital deafness in the left ear, the patient now presents with a complete loss of hearing.The physician suggests that the hearing loss in the right ear was caused by other factors such as neuropathy beside the ossicle, a progressive neurological disease, and the fact that cholesteatoma otitis media can lead to hearing loss.The physician does not believe the hearing loss is a result of the medtronic device.A cochlear implant may be implanted at a later date.

Manufacturer Narrative

(b)(4).The device remains implanted in the patient.Therefore, a product analysis cannot be performed.This device is used for therapeutic purposes.

• Brand Name: PROSTHESIS - POLYCEL
• Type of Device: POROUS POLYETHYLENE OSSICULAR REPLACEMENT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 4700131
• MDR Text Key: 5723921
• Report Number: 1045254-2015-00122
• Device Sequence Number: 1
• Product Code: LBM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K823442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 1156376
• Device Catalogue Number: 1156376
• Device Lot Number: 0206054172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2015
• Initial Date FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 00041 YR