MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1000 MED-EL CONCERT

Device Problems Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the mfr for eval.When available, a device failure analysis will be submitted as a follow up report.

Event Description

Since implantation the pt was having problems to wear the external device due to thick skin flap.Furthermore, recently some of the basal electrode channels have been progressively turned off.As following these symptoms, the surgeon decided to re-implant the pt.

Manufacturer Narrative

Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.According to the patient report the device was explanted due to coupling issues since implantation, most likely due to the patient's skin flap thickness.During explantation surgery the surgeon removed the periosteum above the implant coil.Additionally the active electrode array was not fully inserted during initial surgery.The investigation results appear to match the problems mentioned in the patient report.Despite requested, no further information has been received.This is a final report.

Event Description

Since implantation the patient has had problems wearing the external device due to thick skin flap.In addition some of the basal electrode channels have been progressively turned off.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 4928003
• MDR Text Key: 22407749
• Report Number: 9710014-2015-00495
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737083632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 54 YR