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

Model Number MI1000 MED-EL CONCERT

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Fall (1848); Failure of Implant (1924); Therapeutic Response, Decreased (2271)

Event Date 04/01/2015

Event Type  Injury  

Event Description

It was reported that in situ testing showed 10 electrode channels with status hi.Previously, in situ measurements had been within norman limits on all channels.Reportedly the patient fell in (b)(6), and this was the first time since the fall that the patient has been seen by audiologist.Patient reports that sound is very low nad not even worth wearing and has been this way since her fall.The patient will see the surgeon and imagings has been recommended.

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Manufacturer Narrative

(b)(4).According to the currently available information, it appears the problems with the active electrode are most likely broken wires due to the reported accident.To determine an exact root cause, a device investigation of the explanted device is necessary.As and when the device is received for investigation, the complaint will be reopened.

Event Description

It was reported that in-situ testing showed 10 electrode channels with status high impedance.Previously, in-situ measurements had been within normal limits on all channels.Reportedly the patient fell in august, and this was the first time since the fall that the patient has been seen by audiologist.Patient reports that sound is very low and not even worth wearing and has been this way since her fall.

Manufacturer Narrative

(b)(4) (exemption number e2015033).Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The problems given in the patient report and the reported accident appear to match the damage found.This is a final report.

Event Description

It was reported that in-situ testing showed 10 electrode channels with status high impedance.Previously, in-situ measurements had been within normal limits on all channels.Reportedly the patient fell in (b)(6) 2014, but this was the first time since the fall that the patient has been seen by the audiologist.Patient reports that sound is very low and not even worth wearing, it has been this way since her fall.

• 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: 4723997
• MDR Text Key: 5746093
• Report Number: 9710014-2015-00289
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Other Device ID Number: (01) 09008737062682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2015
• 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: 63 YR