MAUDE Adverse Event Report: MED-EL CONCERT; IMPLANT, COCHLEAR

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

Patient Problems Pain (1994); Twitching (2172)

Event Date 04/05/2016

Event Type  malfunction  

Event Description

Explanted (med-el concert) cochlear implant due to patient complaints of facial twitching and pain.Actual date of device problems unknown.

• Brand Name: CONCERT
• Type of Device: IMPLANT, COCHLEAR
• Manufacturer (Section D): MED-EL; 2511 old cornwallis road; suite 100; durham NC 27713
• MDR Report Key: 5569451
• MDR Text Key: 42410150
• Report Number: 5569451
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 79